Systems and methods for phlebotomy through a peripheral iv catheter

ABSTRACT

An apparatus includes a catheter, an introducer having a first member and a second member, a locking mechanism coupled to a distal end of the first member and configured to couple the introducer to a peripheral intravenous line, and an actuator coupled to the catheter. The actuator is configured to move from a first configuration, in which the catheter is disposed within the introducer, toward a second configuration to move the second member to a distal position relative to the first member. A portion of a guide of the second member being distal to the first member when the second member is in the distal position. The actuator is configured to move relative to the second member to be placed in the second configuration when the second member is in its distal position such that the catheter is disposed within and extending past an end of the peripheral intravenous line.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/468,826, entitled, “Systems and Methods for Phlebotomy Through aPeripheral IV Catheter,” filed Aug. 26, 2014, which is acontinuation-in-part of U.S. patent application Ser. No. 13/758,585entitled, “Systems and Methods for Phlebotomy Through a Peripheral IVCatheter,” filed Feb. 4, 2013, which is a continuation of U.S. patentapplication Ser. No. 13/456,900 entitled, “Systems and Methods forPhlebotomy Through a Peripheral IV Catheter,” filed Apr. 26, 2012, nowU.S. Pat. No. 8,366,685, which is a continuation-in-part of U.S. patentapplication Ser. No. 13/234,857 entitled, “Systems and Methods forPhlebotomy Through a Peripheral IV Catheter,” filed on Sep. 16, 2011,which claims priority under 35 U.S.C. 119(e) to U.S. Provisional PatentApplication Ser. No. 61/479,223 entitled, “Systems and Methods forPhlebotomy Through a Peripheral IV Catheter,” filed on Apr. 26, 2011,the disclosures of which are incorporated herein by reference in theirentireties.

BACKGROUND

The embodiments described herein relate generally to medical devices.More particularly, the embodiments described herein relate to systemsand methods for phlebotomy through an intravenous catheter.

The typical hospitalized patient encounters a needle every time a doctororders a lab test. The standard procedure for blood extraction involvesusing a metal needle (“butterfly needle”) to “stick” patients' veins intheir arms or hands. Blood drawing is a manual, labor-intensive process,with the average patient requiring hours of direct skilled labor duringa typical hospital stay. This needle stick is not only painful and amajor source of patient dissatisfaction, but the nurses or specializedblood drawing personnel (phlebotomists) often have difficulty findingthe vein in approximately 10-15% of patients, resulting in multiple,painful “stick” attempts. This results in significantly higher materialand labor costs (needles and tubing must be disposed of after everyattempt) and increased patient pain and bruising.

The current process for drawing blood is inefficient, taking on average7-10 minutes, and more than 21 minutes for 10% of patients. These 10% ofpatients are referred to as Difficult Intra-Venous Access or morecommonly as “tough stick” patients. If superficial veins are not readilyapparent, blood can be forced into the vein by massaging the arm fromwrist to elbow, tapping the site with the index and middle finger,applying a warm, damp washcloth to the site for 5 minutes, or bylowering the extremity over the bedside to allow the veins to fill. Eachof these methods is time consuming and therefore costly.

Peripheral IV catheters (PIVs) are inserted into most patients whilethey are hospitalized and used for infusing fluids and medications.However, they are not designed for blood extractions. The failure ratesfor aspiration reach 20-50% when PIVs have been left inserted for morethan a day. Blood extracted from PIVs is often hemolyzed (e.g., definedas the rupture of red blood cells and the release of their contents intosurrounding fluid) resulting in a discarded sample and the need torepeat the blood collection.

There are several mechanical barriers that can contribute to theshortcomings of extracting blood from a PIV. First, most catheters areformed from a soft bio-reactive polymer, the use of this material hasled to a potential narrowing or collapse of the catheter as the negativepressure is applied for aspiration or the catheter is kinked duringinsertion or manipulation, preventing backflow. Additionally, withlonger indwelling times comes an increase in debris (e.g.,fibrin/platelet clots) that build up on the tip of the catheter andwithin the lumen. This explains the relationship between failure rateand indwelling time. A third significant barrier is attributed to a“suction cup” effect, wherein the negative pressure created byaspiration through the catheter and the possible curved path of a veinresult in the tip of the catheter adhering to the wall of the vein. Asthe negative pressure increases the vein can rupture resulting in“blowing the vein,” a major concern for phlebotomists during aspirationthrough a PIV.

Thus, a need exists for an improved system and method for phlebotomythrough a peripheral intravenous catheter.

SUMMARY

Systems and methods for phlebotomy through a peripheral intravenouscatheter are described herein. In some embodiments, an apparatusincludes a catheter having a proximal end portion and a distal endportion and defining a lumen therethrough, an introducer having a firstmember and a second member, a locking mechanism coupled to a distal endof the first member, and an actuator coupled to the catheter. At least aportion of the second member is movably disposed in the first memberbetween a proximal position and a distal position relative thereto. Thesecond member includes a guide having a distal end portion that isdisposed in a distal position relative to the first member when thesecond member is in the distal position. The locking mechanism isconfigured to couple the introducer to a peripheral intravenous line. Atleast a portion of the actuator is disposed in the second member and isconfigured to move from a first configuration toward a secondconfiguration to move the second member from its proximal position toits distal position. The actuator is configured to move relative to thesecond member to be placed in the second configuration when the secondmember is in its distal position. The catheter is disposed within theintroducer when the actuator is in the first configuration and isdisposed within and extending past an end of the peripheral intravenousline when in the actuator is in the second configuration.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1 and 2 are schematic illustrations of an apparatus in a firstconfiguration and a second configuration, respectively, according to anembodiment.

FIG. 3 is a detailed schematic illustration of an apparatus in a secondconfiguration, according to an embodiment.

FIG. 4 is a detailed schematic illustration of an apparatus in a secondconfiguration, according to an embodiment.

FIGS. 5 and 6 are cross-sectional side views of an apparatus in a firstconfiguration and a second configuration, respectively, according to anembodiment.

FIG. 6A is an enlarged view of a portion of the apparatus of FIG. 6,indicated by the region X.

FIGS. 7 and 8 are cross-sectional side views of an apparatus and anadapter in a first configuration and a second configuration,respectively, according to an embodiment.

FIG. 9 is a perspective view of an apparatus in a first configuration,according to an embodiment.

FIG. 10 is an exploded view of the apparatus illustrated in FIG. 9.

FIG. 11 is a cross-sectional perspective view of the apparatusillustrated in FIG. 9.

FIG. 12 is a perspective view of the apparatus illustrated in FIG. 9, ina second configuration.

FIG. 13 is a cross-sectional perspective view of the apparatusillustrated in FIG. 9, in the second configuration.

FIG. 13A is an enlarged view of a portion of the apparatus of FIG. 13,indicated by the region Y.

FIG. 14 is a cross-sectional perspective view of the apparatusillustrated in FIG. 9, in a third configuration.

FIGS. 15 and 16 are a side view of an apparatus in a first configurationand a second configuration, respectively, according to an embodiment.

FIG. 17 is a perspective view of the apparatus illustrated in FIG. 15,in the second configuration.

FIG. 18 is an exploded side view of the apparatus of FIG. 15 and anadapter, according to an embodiment.

FIG. 19 is a side view of the apparatus and adapter illustrated in FIG.18, in a first configuration.

FIG. 20 is a side view of the apparatus and the adapter illustrated inFIG. 18, in a second configuration.

FIG. 21 is a perspective view of the apparatus illustrated in FIG. 18,in the second configuration.

FIG. 22 is an enlarged view of a portion of the apparatus of FIG. 18,indicated by the region Z in FIG. 21.

FIGS. 23 and 24 are schematic illustrations of an apparatus in a firstconfiguration and a second configuration, according to an embodiment.

FIGS. 25 and 26 are schematic illustrations of an apparatus in a firstconfiguration and a second configuration, according to an embodiment.

FIGS. 27 and 28 are schematic illustrations of an apparatus in a firstconfiguration and a second configuration, according to an embodiment.

FIGS. 29-37 are side views of various catheter configurations includedin an apparatus, according to an embodiment.

FIGS. 38-43 are various views of two-port adapters, according to variousembodiments.

FIGS. 44 and 45 are views of single-port adapters, according toembodiments.

FIG. 46 is a flowchart illustrating a method of phlebotomy through aperipheral intravenous line, according to an embodiment.

FIG. 47 is a perspective view of a fluid transfer device according toanother embodiment.

FIG. 48 is an exploded view of the fluid transfer device of FIG. 47.

FIG. 49 is a perspective view of a first introducer member included inthe fluid transfer device of FIG. 47.

FIG. 50 is a cross-sectional view of the first introducer member takenalong the line 50-50 in FIG. 49.

FIG. 51 is a cross-sectional view of the first introducer member takenalong the line 51-51 in FIG. 50.

FIG. 52 is a cross-sectional view of the first introducer member takenalong the line 52-52 in FIG. 50.

FIG. 53 is a perspective view of a second introducer member included inthe fluid transfer device of FIG. 47.

FIG. 54 is a cross-sectional view of the second introducer member takenalong the line 54-54 in FIG. 53.

FIG. 55 is a cross-sectional view of the first introducer member takenalong the line 50-50 in FIG. 49 and the second introducer member takenalong the line 54-54 in FIG. 53.

FIG. 56 is a perspective view of an actuator included in the fluidtransfer device of FIG. 47.

FIG. 57 is a cross-sectional view of the actuator taken along the line57-57 in FIG. 56.

FIG. 58 is a rear view of the fluid transfer device of FIG. 47.

FIG. 59 is a cross-sectional view of the fluid transfer device takenalong the line 59-59 in FIG. 58, in a first configuration.

FIG. 60 is an enlarged view of a portion of the fluid transfer device ofFIG. 59 indicated by the region A₁.

FIG. 61 is an enlarged view of a portion of the fluid transfer device ofFIG. 59 indicated by the region A₂.

FIG. 62 is an enlarged view of a portion of the fluid transfer device ofFIG. 59 indicated by the region A₃.

FIG. 63 is a cross-sectional view of the fluid transfer device takenalong the line 59-59 in FIG. 58, in a second configuration.

FIG. 64 is an enlarged view of a portion of the fluid transfer device ofFIG. 63 indicated by the region A₄.

FIG. 65 is a cross-sectional view of the fluid transfer device takenalong the line 59-59 in FIG. 58, in a third configuration.

FIG. 66 is an enlarged view of a portion of the fluid transfer device ofFIG. 65 indicated by the region A₅.

FIGS. 67 and 68 are cross-sectional views of the fluid transfer deviceof FIG. 47 taken along the line 67-67, in the third configuration and afourth configuration, respectively.

FIG. 69 is a top view of a first member of an introducer according toanother embodiment.

FIG. 70 is a rear view of the first member of FIG. 69.

FIG. 71 is a cross-sectional view of the first member taken along theline 71-71 in FIG. 70.

FIG. 72 is an enlarged view of a portion of the first member identifiedin FIG. 71 by the region A₆.

FIG. 73 is a top view of an actuator according to another embodiment.

FIG. 74 is a rear view of the actuator of FIG. 73.

FIG. 75 is a cross-sectional view of the actuator taken along the line75-75 in FIG. 74.

FIG. 76 is an enlarged view of a portion of the actuator identified inFIG. 75 by the region A7.

FIG. 77 is a flowchart illustrating a method of phlebotomy through aperipheral intravenous line, according to another embodiment.

FIGS. 78 and 79 are schematic illustrations of a distal end portion of acatheter according to different embodiments.

DETAILED DESCRIPTION

Systems and methods for phlebotomy through a peripheral intravenouscatheter are described herein. In some embodiments, an apparatusincludes a catheter having a proximal end portion and a distal endportion and defining a lumen therethrough, an introducer having a firstmember and a second member, a locking mechanism coupled to a distal endof the first member, and an actuator coupled to the catheter. At least aportion of the second member is movably disposed in the first memberbetween a proximal position and a distal position relative thereto. Thesecond member includes a guide having a distal end portion that isdisposed in a distal position relative to the first member when thesecond member is in the distal position. The locking mechanism isconfigured to couple the introducer to a peripheral intravenous line. Atleast a portion of the actuator is disposed in the second member and isconfigured to move from a first configuration toward a secondconfiguration to move the second member from its proximal position toits distal position. The actuator is configured to move relative to thesecond member to be placed in the second configuration when the secondmember is in its distal position. The catheter is disposed within theintroducer when the actuator is in the first configuration and isdisposed within and extending past an end of the peripheral intravenousline when in the actuator is in the second configuration.

In some embodiments, an apparatus includes a catheter, a firstintroducer, a second introducer, and an actuator. The catheter has aproximal end portion and a distal end portion and defining a lumentherethrough. The first introducer has a proximal end portion, a distalend portion, and an inner surface defining a channel. The distal endportion of the first introducer is configured to be coupled to aperipheral intravenous line. The second introducer has a proximal endportion and a distal end portion. The distal end portion of the secondintroducer includes a guide member. At least a portion of the secondintroducer is movably disposed in the first introducer such that aprotrusion extending from an outer surface of the second introducer isdisposed in the channel. The second introducer has a range of motionrelative to the first introducer defined at least in part by thechannel. The actuator is coupled to the catheter and is at leastpartially disposed in the second introducer. The actuator is configuredto move the second introducer through at least a portion of the range ofmotion to advance a distal end portion of the guide member through theperipheral intravenous line. The actuator is configured to move from afirst position relative to the second introducer, in which the catheteris disposed in the guide member, to a second position relative to thesecond introducer, in which the distal end portion of the catheterextends beyond a distal end of the guide member.

In some embodiments, a method includes coupling a fluid transfer deviceto a peripheral intravenous line. The fluid transfer device includes anintroducer having a first member and second member. The second memberincludes a guide member and is movably disposed in the first member. Thefluid transfer device includes an actuator movably disposed in thesecond member and a catheter coupled to the actuator. A first force isexerted on the actuator. The first force is sufficient to move thesecond member relative to the first member from a first position, inwhich the guide member is disposed in the first member, to a secondposition, in which a distal end portion of the guide member is insertedthrough a port of the peripheral intravenous line. A second force isexerted on the actuator. The second force is sufficient to move theactuator relative to the second member when the second member is in thesecond position to advance the catheter from a first position, in whichthe catheter is disposed in the introducer, to a second position, inwhich a distal end portion of the catheter extends past an end of theperipheral intravenous line. A fluid reservoir is coupled to the fluidtransfer device such that the fluid reservoir is fluidically coupled tothe catheter. The catheter is withdrawn from the peripheral intravenousline after a volume of bodily fluid is transferred to the fluidreservoir such that the catheter is disposed within the introducer.

In some embodiments, an apparatus includes a cannula or catheter, anintroducer, a locking mechanism, and an actuator. The catheter includesa proximal end and a distal end and defines a lumen. The introducerincludes a proximal end and a distal end and defines a lumen configuredto receive at least a portion of the catheter. The locking mechanism iscoupled to the distal end of the introducer and is configured to couplethe introducer to a peripheral intravenous line. The actuator isoperatively coupled to the catheter and is configured to move thecatheter between a first configuration, in which the catheter issubstantially within the introducer, and a second configuration, inwhich the catheter is substantially outside the introducer. The catheterextends past an end of the peripheral intravenous line when in thesecond configuration.

In some embodiments, a method includes coupling an introducer to aperipheral intravenous line (e.g., saline locked device, heparin lockeddevice, or the like), the introducer having a proximal end and a distalend. The method further includes advancing a catheter from a firstposition inside the introducer and outside the peripheral intravenousline to a second position substantially outside the introducer andinside the peripheral intravenous line. In some embodiments, thecatheter has a length greater than a length of the peripheralintravenous line, while in other embodiments, the catheter, in thesecond position, is shorter than the peripheral intravenous line. Themethod includes coupling a container to the proximal end of theintroducer such that the container is fluidically coupled to thecatheter. The method further includes withdrawing the catheter from thesecond position to the first position.

In some embodiments, a catheter has a proximal end and a distal end anddefines a lumen therethrough. An introducer has a proximal end and adistal end and defines a lumen therethrough. The introducer isconfigured to receive the catheter therein. An adapter is coupled to theintroducer. The adapter has a distal end configured to be coupled to aperipheral intravenous line. The adapter defines a first lumen and asecond lumen. The first lumen has a first diameter and is configured toreceive the catheter therethrough. The second lumen is orthogonal to thefirst lumen. An actuator is operatively coupled to the catheter and isconfigured to move the catheter between a first configuration and asecond configuration. The catheter extends past the distal end of theadapter in the second configuration.

As used herein, the terms “catheter” and “cannula” are usedinterchangeably to describe an element configured to define a passagewayfor moving a bodily fluid from a first location to a second location(e.g., a fluid passageway to move a bodily fluid out of the body). Whilecannulas can be configured to receive a trocar, a guide wire, or anintroducer to deliver the cannula to a volume inside the body of apatient, the cannulas referred to herein need not include or receive atrocar, guide wire, or introducer.

As used in this specification, the terms “Y-adapter” and “T-adapter” areused to refer to a dual port IV extension set. In this manner, the terms“Y-adapter” and “T-adapter” generally describe an overall shape of thedual port IV extension set. For example, as used herein, a Y-adapter issubstantially “Y” shaped including a single port at a first end and twoports angularly disposed at a second end. Furthermore, the terms“Y-adapter” and “T-adapter” are included by way of example only and notlimitation. For example, in some embodiments, an apparatus can include asingle port IV extension set (e.g., a single port adapter) or amulti-port IV extension set (e.g., an adapter with more than two ports).

As used in this specification, the words “proximal” and “distal” referto the direction closer to and away from, respectively, a user who wouldplace the device into contact with a patient. Thus, for example, the endof a device first touching the body of the patient would be the distalend, while the opposite end of the device (e.g., the end of the devicebeing manipulated by the user) would be the proximal end of the device.

As used herein, the term “stiffness” relates to an object's resistanceto deflection, deformation, and/or displacement by an applied force.Stiffness can be characterized in terms of the amount of force appliedto the object and the resulting distance through which a first portionof the object deflects, deforms, and/or displaces with respect to asecond portion of the object. When characterizing the stiffness of anobject, the deflected distance may be measured as the deflection of aportion of the object different from the portion of the object to whichthe force is directly applied. Said another way, in some objects, thepoint of deflection is distinct from the point where force is applied.

Stiffness is an extensive property of the object being described, andthus is dependent upon the material from which the object is formed aswell as certain physical characteristics of the object (e.g., shape andboundary conditions). For example, the stiffness of an object can beincreased or decreased by selectively including in the object a materialhaving a desired modulus of elasticity, flexural modulus, and/orhardness. The modulus of elasticity is an intensive property of (i.e.,is intrinsic to) the constituent material and describes an object'stendency to elastically (i.e., non-permanently) deform in response to anapplied force. A material having a high modulus of elasticity will notdeflect as much as a material having a low modulus of elasticity in thepresence of an equally applied stress. Thus, the stiffness of the objectcan be increased, for example, by introducing into the object and/orconstructing the object of a material having a high modulus ofelasticity.

Similarly, a material's hardness is an intensive property of theconstituent material and describes the measure of how resistant thematerial is to various kinds of permanent shape change when a force isapplied. In discussing the hardness and the subsequent effect on thestiffness of a catheter, the Shore durometer scale is generally used.There are several scales for durometers with two commonly used indescribing plastics, polymers, elastomers, and/or rubbers, namely, typeA and type D, where type A is generally used for softer materials andtype D is generally used for harder materials. The Shore durometer of amaterial is denoted by a number between 0 and 100, with higher numbersindicating a harder material, followed by the type of scale. Forinstance, a first material can be measured as having a Shore durometerof 40 Shore A and a second material can be measured as having a Shoredurometer of 60 Shore D. Therefore, according to the Shore durometerscale, the second material is harder and thus, more stiff than the firstmaterial.

FIGS. 1 and 2 are schematic illustrations of an apparatus 1000 forphlebotomy through a peripheral intravenous line or catheter in a firstconfiguration and second configuration, respectively, according to anembodiment. The apparatus 1000 includes an introducer 1100, a cannula orcatheter 1200, a lock mechanism 1131, and an actuator 1500. Theintroducer 1100 includes a sheath 1110 having a proximal end 1120 and adistal end 1130 and defining a lumen 1113. The catheter/cannula 1200 ismovably disposed within sheath 1110 between the proximal end 1120 andthe distal end 1130.

The proximal end 1120 includes a port 1121, such that thecatheter/cannula 1200 can move from the first, retracted configuration(FIG. 1) to the second, extended configuration (FIG. 2). Similarlystated, the port 1121 at the proximal end 1120 of the introducer 1100 isconfigured such that the catheter 1200 may move through the port 1121from the first configuration to the second configuration. The port 1121can be any suitable port such as, for example, an opening in theproximal end 1120 of the introducer 1100. Furthermore, the port 1121 caninclude any suitable seal member such as an O-ring or a gasket. In someembodiments, the port 1121 can be a self-sealing port and can belubricated using any suitable lubrication to aid in the movement and/orsealing of the catheter 1200 therein.

The distal end 1130 of the introducer 1100 includes a locking mechanism1131 configured to fluidically couple a peripheral intravenous line 1300to the introducer 1100 and place the catheter 1200 into fluidcommunication with the peripheral intravenous line 1300. The lockingmechanism 1131 can be any suitable locking mechanism that creates afluid-tight seal. In some embodiments, the locking mechanism can be aLuer Lok™ or similar configuration. In some embodiments, the peripheralintravenous line 1300 is in a sealed configuration until the lockingmechanism 1131 is coupled to the intravenous line 1300. Once the lockingmechanism 1131 is coupled to the intravenous line 1300, the seal can beopened to allow access for the catheter 1200. In some embodiments, thelocking mechanism can include a back flow prevention mechanism such as aone-way valve or the like. In this manner, the lock mechanism 1131 canbe configured to allow the catheter 1200 to pass through the lockmechanism 1131 but substantially prevent a fluid flow, outside thecatheter 1200, through the lock mechanism 1131.

The catheter 1200 defines a lumen 1201 between a proximal end 1220 and adistal end 1230 and may be any suitable diameter and stiffness. In someembodiments, the catheter 1200 can be between a 16-gauge and 26-gaugeand have a Shore durometer of approximately 20 Shore A to 50 Shore D. Insome embodiments, the catheter 1200 has a Shore durometer ofapproximately 20 Shore A to 95 Shore D. In some embodiments, thecatheter 1200 has a Shore durometer of approximately 70 Shore D to 85Shore D. In this manner, the catheter 1200 can be any suitable diameterto be inserted through the peripheral intravenous line 1300 and can besufficiently stiff to be advanced through the peripheral intravenousline 1300.

The actuator 1500 is operatively coupled to the catheter 1200 through agroove or slot 1111 in the introducer 1100. The actuator 1500 isconfigured to move the catheter 1200 from the first configuration to thesecond configuration such that the distal end 1230 of the catheter 1200is substantially outside the introducer 1100, as shown in FIG. 2. Insome embodiments, the length of the distal end 1230 of the catheter 1200is greater than the length of the peripheral intravenous line 1300. Inthis manner, the distal end 1230 of the catheter 1200 extends past thedistal end of the intravenous line 1300.

In some embodiments, the catheter 1200 can be moved to a thirdconfiguration in which the catheter 1200 is retracted back into theintroducer 1100. The third configuration can be substantially similar tothe first configuration (FIG. 1) in that the catheter 1200 is positionedin the introducer 1100, thus, the user does not come into contact withbodily fluids. While in the first configuration and the thirdconfiguration, the apparatus 1000 can be disconnected from or connectedto a peripheral intravenous line 1300. Said another way, the apparatus1000 can be in the first configuration before it is coupled to theperipheral intravenous line 1300, then remain in the first configurationfor a period of time after being coupled to the peripheral intravenousline 1300. Similarly, the apparatus 1000 can be moved to the thirdconfiguration, be disconnected from the peripheral intravenous line1300, and then remain in the third configuration.

FIG. 3 is a detailed schematic illustration of an apparatus 2000according to an embodiment in a second configuration. In someembodiments, the apparatus 2000 is substantially similar to theapparatus 1000 described above in reference to FIGS. 1 and 2. Therefore,aspects of the apparatus 2000 are not described in detail herein. Theapparatus 2000 includes an introducer 2100 and a catheter 2200. Thecatheter 2200 includes a proximal end 2220 and a distal end 2230. Thedistal end 2230 of the catheter 2200 includes a set of openings 2231such that when in the second configuration (e.g., when the distal end2230 of the catheter 2200 is in the vein and outside the intravenousline) the openings 2231 act to transport a bodily fluid (e.g., blood) toa volume outside the catheter 2200. The set of openings 2231 can be ofany arrangement on the circumference of the catheter 2200 and caninclude the end of the catheter 2200. Similarly stated, the catheter2200 having the distal end 2230 can define an opening at the tipsurface. Each opening 2231 can be of any suitable shape or size and arenot necessarily similar to any other opening included in the set ofopenings 2231. In some embodiments, the catheter 2200 defines a singleopening. For example, in some embodiments, the catheter 2200 defines asingle opening 2231 at the distal surface.

The proximal end 2220 of the catheter 2200 is fluidically coupled to alocking mechanism 2221, as shown in FIG. 3. The locking mechanism 2221can be any suitable locking mechanism such as a Luer Lok™ or the like. Aneedle 2222 is fluidically coupled to the locking mechanism 2221 and atleast partially disposed within a sheath 2223. The sheath 2223 can beany material with a suitable flexibility and/or compressibility suchthat the needle 2222 can extend through the sheath 2223 when engagedwith a conventional phlebotomy fluid container (e.g., a Vacutainer®).The locking mechanism 2221 is configured to be coupled to any suitablefluid containment system such as a Vacutainer® holder (not shown in FIG.3) and place the needle 2222 in fluid communication with the fluidcontainment system. The sheath 2223 is configured to compress when thelocking mechanism 2221 is coupled to the fluid containment system. Thisarrangement facilitates the passage of bodily fluids through the set ofopenings 2231 of the catheter 2200, as shown in FIG. 3 by arrow AA,through the catheter 2200, and exiting the catheter 2200 through theneedle 2222, as shown in FIG. 3 by arrow BB.

FIG. 4 is a schematic illustration of an apparatus 3000 for phlebotomythrough a peripheral intravenous catheter in a second configurationaccording to an embodiment. The apparatus 3000 includes an introducer3100 and a catheter 3200. The introducer 3100 includes a sheath 3110defining a lumen 3113 between a proximal end 3120 and a distal end 3130and configured to house, at least partially, the catheter 3200. Thedistal end 3130 of the introducer 3100 includes a locking mechanism 3131configured to fluidically couple the introducer 3100 to a peripheralintravenous line 3300 and place the catheter 3200 into fluidcommunication with the peripheral intravenous line 3300, when thecatheter 3200 is in the second configuration. The locking mechanism 3131can be any suitable locking mechanism that creates a fluid-tight seal.In some embodiments, the locking mechanism 3131 can be a Luer Lok™ orsimilar configuration. The sheath 3110, having a given stiffness, isconfigured such that when applying a force to the proximal end 3120 (asindicated by the arrow CC in FIG. 4), the sheath 3110 compresses alongan axis AAA.

The compression of the sheath 3110 is such that the catheter 3200 isadvanced to the second configuration. Said another way, as the sheath3110 of the introducer 3100 is compressed, the catheter 3200 moves froma first configuration where in the catheter 3200 is disposed within theintroducer 3100 (as described above with respect to FIG. 1) to a secondconfiguration wherein the distal end 3230 is substantially outside theintroducer 3100, as shown in FIG. 4. Furthermore, the stiffness of thesheath 3110 is an extensive property and as such can have a set ofproperties (i.e. material, thickness, shape and/or the like) to allowthe sheath 3110 to compress along the axis AAA with the desired amountof force applied at the proximal end 3120 of the introducer 3100. Theset of properties allow the sheath 3110 to elastically deform (i.e.non-permanently) such that when the force is no longer applied to theproximal end 3120 of the introducer 3100, the apparatus 3000 returns tothe first configuration. In the second configuration, the distal end3230 of the catheter 3200 extends past the distal end of the peripheralintravenous line 3300. This arrangement allows for the transport of abodily fluid to a volume outside the catheter 3200 and when complete,the apparatus 3000 can be placed in a third configuration, substantiallysimilar to the first configuration.

FIGS. 5 and 6 are side views of an apparatus 4000 according to anembodiment in a first configuration and a second configuration,respectively. The apparatus 4000 includes an introducer 4100 and acatheter 4200. The introducer 4100 includes a sheath 4110 defining alumen 4113 between a proximal end 4120 and a distal end 4130 and isconfigured to house, at least partially, the catheter 4200. Althoughshown in FIG. 5 as being cylindrical, the introducer 4100 can be anysuitable shape. Moreover, the lumen 4113, defined by the interior wallsof the sheath 4110 is not necessarily the same shape as the exteriorwalls of the sheath 4110. Said a different way, the interior andexterior walls of the sheath 4110 can have a different cross sectionalshape. The proximal end 4120 of the introducer 4100 is coupled to alocking mechanism 4122. The locking mechanism 4122 can be any suitablelocking mechanism such as a Luer Lok™ or the like. In use, the lockingmechanism 4122 is configured to couple to a suitable fluid containmentsystem such as a Vacutainer® holder (not shown in FIG. 5) to place thecatheter 4200 in fluid communication with the fluid containment system.

The distal end 4130 of the introducer 4100 includes a locking mechanism4131 configured to fluidically couple the introducer 4100 to aperipheral intravenous line (not shown in FIG. 5). In this manner, thelocking mechanism 4131 can be configured to selectively place thecatheter 4200 into fluid communication with the peripheral intravenousline. The locking mechanism 4131 can be any suitable locking mechanismthat creates a fluid-tight seal. In some embodiments, the lockingmechanism 4131 is in a sealed configuration until the locking mechanism4131 is coupled to the intravenous line. Once the locking mechanism 4131is coupled to the intravenous line, the seal can be opened to allowaccess for the catheter 4200. In addition, while in the unlockedconfiguration, the locking mechanism 4131 of the distal end 4130 and thelocking mechanism 4122 of the proximal end 4120 create a fluidicallyisolated housing for the catheter 4200 therein. Stated similarly, priorto the proximal end locking mechanism 4122 and distal end lockingmechanism 4131 being unlocked and before the catheter 4200 is in thesecond configuration, the catheter 4200 is sterile. Furthermore, thecatheter 4200, when in the second configuration and having contacted thedesired bodily fluid, can be moved to a third configuration (e.g.,substantially similar to the first configuration) thereby isolating theused distal end 4230.

The sheath 4110 has a given stiffness such that when a force (asindicated by the arrow DD in FIG. 6) is applied to the proximal end4120, the sheath 4110 compresses along an axis BBB. The compression ofthe sheath 4110 is such that the catheter 4200 is advanced to the secondconfiguration. Said another way, as the sheath 4110 of the introducer4100 is compressed, the catheter 4200 moves from the first configurationwherein the catheter 4200 is disposed within the introducer 4100 to thesecond configuration wherein the distal end 4230 is substantiallyoutside the introducer 4100 (e.g., the sheath 4110 retracts). Theproperties of the sheath 4110 can be any set of properties discussedherein such that applying a desired amount of force to proximal end 4120allows the sheath to compress along axis BBB. In the secondconfiguration, the distal end 4230 of the catheter 4200 extends past thedistal end of the peripheral intravenous line and allows for thetransport of a bodily fluid to a volume outside of the catheter 4200.

The catheter 4200 includes a distal end 4230 and tapered portion 4203.The tapered portion is such that the diameter of the catheter 4200 isreduced at a given location, as shown in FIG. 5. The taper angle θ canbe any suitable angle such that the catheter 4200 is allowed to advancefully to the second configuration (FIG. 6). Moreover, the taper angle θis such that a laminar flow (i.e., smooth layered flow) is achieved. Insome embodiments, the catheter 4200 can include a stiffening wire 4202,as shown in FIG. 6A, and can be configured to coil around the walls ofthe catheter 4200 providing the catheter 4200 with a desired stiffness.Moreover, the stiffening wire 4202, being coiled around the catheter4200, can provide the flexibility to advance through a set of wallsdefining a lumen (i.e., veins, arteries, peripheral intravenous line,and/or the like) without kinking or binding. In addition, the stiffeningwire 4202 can provide the catheter 4200 with enough stiffness tofacilitate its advancement through the lumen.

The distal end 4230 of the catheter 4200 includes a set of openings 4231such that when in the second configuration (e.g., when the distal end4230 of the catheter 4200 is in the vein and outside the intravenousline) the openings 4231 act to transport a bodily fluid (i.e., blood) toa volume outside the catheter 4200. The set of openings 4231 can be ofany arrangement on the circumference of the catheter 4200 and caninclude the end of the catheter 4200. Similarly stated, the catheter4200 having the distal end 4230 can be substantially open at the tipsurface. Although FIGS. 6 and 6A show the distal end 4230 of thecatheter 4200 as substantially flat, the distal end 4230 may be anysuitable shape, (e.g. conical or spherical) and can have any suitabledegree of rounded edges. Each opening 4231 can be of any suitable shapeor size and are not necessarily similar to any other opening 4231included in the set of openings 4231. The arrangement of the set ofopenings 4231 is configured to introduce a laminar flow through catheter4200 to a volume substantially outside the catheter 4200 and thus avoidhemolysis.

In some embodiments, a blood collection system consists of two elements:(1) the introducer/catheter blood collection assembly described above;and (2) a y-adapter that is configured to attach to a standard 16 g or22 g peripheral IV catheter. The y-adapter includes a dedicated port forthe blood collection device and another standard port for conventionalmedicine and fluid infusion.

For example, FIG. 7 includes a cross-sectional view of a y-adapter 5400and an apparatus 5000 in a first configuration, according to anembodiment. The apparatus 5000 includes an introducer 5100 and acatheter 5200. The introducer 5100 includes a sheath 5110 defining alumen 5113 between a proximal end 5120 and a distal end 5130 andconfigured to house, at least partially, the catheter 5200. The catheter5200 includes a proximal end 5220 and a distal end 5230. The apparatus5000 can be substantially similar to the apparatus 4000 described abovewith reference to FIGS. 5 and 6. Therefore, aspects of the apparatus5000 are not described in further detail herein.

In some embodiments, the y-adapter 5400 is configured to be coupledbetween the introducer 5100 and intravenous line 5440. The y-adapterincludes a distal end 5410 and defines a first port 5420 and a secondport 5430. The first port 5420 of the y-adapter 5400 defines a firstlumen 5422 with a first diameter D₁. The first port 5420 is configuredsuch that the first port 5420 is substantially similar in size, shape,configuration, and functionality of a conventional y-adapter. Moreover,the first port 5420 is configured such that the backflow of a bodilyfluid cannot exit the first port 5420. More specifically, the firstlumen 5422 defined by the walls of the first port 5420 can be such thatthe lumen 5422 restricts the backflow of a bodily fluid (i.e. blood). Insome embodiments, the backflow can be prevented using a valve, screwcap, flip cap, port, and/or the like.

The second port 5430 of the y-adapter 5400 defines a second lumen 5432with a second diameter D₂. As shown in FIG. 7, the second diameter D₂can be configured to be larger than first diameter D₁. In otherembodiments, the second diameter D₂ can be similar or smaller than thefirst diameter D₁. More particularly, the diameter D₂ of the second port5430 is large enough to accept up to, for example, an 18-gauge catheter.The y-adapter 5400 can be of any suitable material and/or be of similarmaterial to that of a conventional y-adapter.

The first lumen 5422 defined by the first port 5420 and the second lumen5432 defined by the second port 5430 converge to a common lumen 5401before the distal end 5410 of the y-adapter 5400, as shown in FIG. 7.The second port 5430 is configured such that the second lumen 5432 issubstantially coaxial with the common lumen 5401. Furthermore, thecommon lumen 5401 can have a diameter substantially similar to thediameter D₂ of the second port 5430.

The second port 5430 is fluidically coupled to a locking mechanism 5431configured to couple the y-adapter to the introducer 5100. The lockingmechanism 5431 can be a Luer Lok™ or the like. In some embodiments, they-adapter 5400 is in a sealed configuration until coupled to the lockingmechanism 5131 at the distal end 5130 of the introducer 5100. Once thelocking mechanism 5431 is coupled to the introducer 5100, the seal canbe opened to allow access for the catheter 5200 to advance to a secondconfiguration, shown in FIG. 8 (note the introducer 5100 is not showncoupled to the y-adapter in FIG. 8).

In some embodiments, the distal end 5410 of the y-adapter 5400 iscoupled to a peripheral intravenous line 5440 such as, for example, aconventional peripheral intravenous line. In some embodiments, they-adapter 5400 is monolithically formed with the peripheral intravenousline 5440. In some embodiments, the distal end 5410 of the y-adapter5400 can be coupled to a peripheral intravenous line using any suitablelocking mechanism. Similarly, the second port 5420 of the lockingmechanism 5431 configured to couple the y-adapter 5400 to the introducer5100 can monolithically formed with the introducer 5100. Said anotherway, in some embodiments, a separate introducer is not required, butrather a portion of the y-adapter can serve as the introducer.

When in the second configuration as shown in FIG. 8, the distal end 5230of the catheter 5200 is advanced substantially past the peripheralintravenous line 5440. The distal end 5230 of the catheter 5200 includesa set of openings 5231 such that when in the second configuration (i.e.,when the distal end 5230 of the catheter 5200 is in the vein and outsidethe intravenous line) the openings 5231 act to transport a bodily fluid(i.e., blood) to a volume outside the catheter 5200. The set of openings5231 can be of any arrangement on the circumference of the catheter 5200and can include the end of the catheter 5200. Similarly stated, thecatheter 5200 having the distal end 5230 can be substantially open atthe tip surface. Each opening 5231 can be of any suitable shape or sizeand are not necessarily similar to any other opening included in the setof openings. The catheter 5200, in the second configuration and havingtransported the desired bodily fluid, can be placed in a thirdconfiguration (e.g., substantially similar to the first configurationshown in FIG. 7), thereby isolating the used distal end 5230.

While the introducer 5100 (FIGS. 7 and 8) is described as beingconfigured to be substantially compressed to advance the catheter 5200,in other embodiments, an apparatus can include an actuator configured tomove the catheter relative to the introducer. For example, FIGS. 9-14illustrate an apparatus 6000 used for phlebotomy through a peripheralintravenous line. The apparatus 6000 includes an introducer 6100, acannula 6200, and an adapter 6400. The apparatus 6000 can be anysuitable shape, size, or configuration and is configured to be coupledto, for example, a peripheral intravenous line (PIV) 6300.

The introducer 6100 includes a proximal end 6120 and a distal end 6130.As shown in FIGS. 9-14, the introducer 6100 is a substantiallycylindrical tube configured to receive the cannula 6200. Similarlystated, the introducer 6100 includes a wall or set of walls that definea lumen 6113 (FIG. 11) configured to selectively receive the cannula6200. The introducer 6100 and cannula 6200 can be formed from anysuitable material having any given durometer. In some embodiments, thecannula 6200 can have a durometer between 20 Shore A and 50 Shore D. Inother embodiments, the cannula 6200 can have a Shore durometer ofapproximately 20 Shore A to 95 Shore D. In still other embodiments, thecannula 6200 can have a Shore durometer of approximately 70 Shore D to85 Shore D.

The proximal end 6120 of the introducer 6100 is configured to be coupledto an end cap 6140. In this manner, the end cap 6140 can be configuredto substantially close off and/or seal the proximal end 6120 of theintroducer 6100. In some embodiments, the end cap 6140 is configured toform a substantially fluid-tight seal with the introducer 6100.Similarly stated, in some embodiments, the end cap 6140 and the proximalend 6120 of the introducer 6100 define a substantially hermetic seal. Insome embodiments, the end cap 6140 can be grasped by a user as thecannula 6200 is advanced.

The distal end 6130 of the introducer 6100 is coupled to a lockmechanism 6131. The lock mechanism 6131 is configured to physically andfluidically couple a portion of the apparatus 6000 to the existing PIV6300. In some embodiments, the lock mechanism 6131 can be configured tobe directly coupled to the existing PIV 6300. In other embodiments, thelock mechanism 6131 can be coupled to the adapter 6400 and/or any othersuitable intervening structure, such as, for example, a known valve orcap.

The distal end 6130 of the introducer 6100 can be coupled to the lockmechanism 6131 in any suitable manner. For example, in some embodiments,the distal end 6130 can be disposed within a portion of the lockmechanism 6131 such that an outer surface of the introducer 6100 definesa friction fit with the inner surface of the portion of the lockmechanism 6131. In other embodiments, the distal end 6130 of theintroducer 6100 can be coupled to the lock mechanism 6131 via anadhesive. In still other embodiments, the lock mechanism 6131 can bemonolithically formed with the distal end 6130 of the introducer 6100.For example, in some embodiments, the lock mechanism 6131 can be formedfrom a similar material as the introducer 6100. In other embodiments,the introducer 6100 can be formed from a first material and the lockmechanism 6131 can be formed from a second material configured to beover-molded the distal end 6130 during a manufacturing process.

As seen in FIG. 11, the lock mechanism 6131, includes a seal member 6132configured to define a substantially fluid tight seal when the cannula6200 is in the first configuration. Furthermore, in use, the seal member6132 can be configured to receive a portion of the cannula 6200 to allowthe cannula 6200 to advance, in the distal direction, beyond the sealmember 6132. In this manner, the seal member 6132 can form asubstantially fluid tight seal around the cannula 6200 such that theseal member 6132 substantially prevents a backflow into the introducer6100. The seal member 6132 can be any suitable configuration such as,for example, an O-ring, a one-way valve, a diaphragm, a check valve, orany other suitable seal member. While shown and described as beingincluded in the locking mechanism 6131, in some embodiments, a sealmember can be included in the locking mechanism 6131 and/or the adapter6400. For example, in some embodiments, the locking mechanism 6131 canbe coupled to the adapter 6400 such that the seal member included in theadapter 6400 and/or the locking mechanism 6131 prevents a flow of bodilyfluid in the proximal direction prior to advancing the cannula 6200, asfurther described herein.

As seen in FIGS. 10 and 11, the introducer 6100 further defines anactuator track 6111. The actuator track 6111 can be a slit or openingdefined by the wall of the introducer 6100 and is configured to receivea portion of the actuator 6500. The actuator track 6111 can beconfigured to extend substantially along the length of the introducer6100. In some embodiments, the actuator track 6111 is configured tocontinuously extend through the distal end 6130 and the proximal end6120 of the introducer 6100. The actuator track 6111 can be any suitableconfiguration and can engage the portion of the actuator 6500 in anysuitable manner. For example, in some embodiments, the walls of theintroducer 6100 defining the actuator track 6111 can form a friction fitwith the portion of the actuator 6500, as described in further detailherein.

The cannula 6200 defines a lumen 6201 (FIG. 11) and is configured to bemovably disposed within the introducer 6100. As described above withreference to FIG. 5, the cannula 6200 can be configured to include afirst portion 6205 having a first diameter and a second portion 6210having a second diameter, smaller than the first. More specifically, thefirst portion 6205 is disposed at a proximal end 6220 of the cannula6200 and the second portion 6210 is disposed at a distal end 6230 of thecannula 6200. In this manner, for example, the diameter of the cannula6200 is reduced at the distal end 6230 of the catheter 6200 tofacilitate the insertion of the catheter 6200 into the peripheralintravenous line, as described in further detail herein.

As described above with reference to FIG. 6A, the distal end 6230 of thecannula 6200 can be configured to include any suitable number ofopenings (not shown in FIGS. 9-14. For example, in some embodiments, thedistal end 6230 of the cannula 6200 can include a substantially openend-surface configured to place the lumen 6201 in fluid communicationwith, for example, a vein. In some embodiments, the end surface can besubstantially flat (e.g., perpendicular to a longitudinal axis of thecannula 6200. In other embodiments, the end surface can be any suitableconfiguration such as, for example, substantially bullet-shaped,conical, bulbous, or the like. In still other embodiments, the endsurface can be substantially angled with respect to the longitudinalaxis of the cannula 6200 (e.g., similar to the tip of a needle).Furthermore, in some embodiments, the distal end 6230 can be configuredto include the open end-surface and an opening disposed on the side ofthe cannula 6200. In this manner, the side opening (not shown in FIGS.9-14) can be configured to transfer a portion of a bodily fluid even ifthe opening disposed at the end surface is obstructed (e.g., by a clotor the like).

The actuator 6500 is coupled to the proximal end 6220 of the cannula6200 and is configured to move the cannula 6200, relative to theintroducer 6100, between a first configuration and a secondconfiguration. More specifically, the actuator 6500 defines asubstantially annular shape defining a cavity 6510 configured to receivethe proximal end 6120 of the introducer 6100 and the proximal end 6220of the cannula 6200. Similarly stated, the actuator 6500 is disposedabout the introducer 6100 and the cannula 6200. Furthermore, theactuator 6500 is configured such that a guide member 6520 and a coupler6530 extend from an inner surface of the actuator 6500.

The guide member 6520 can be any suitable shape, size, or configuration.For example, as shown in FIG. 10, the guide member 6520 is a relativelythin extension. In this manner, the guide member 6520 is disposed withinthe actuator track 6111 when the actuator 6500 is disposed about theintroducer 6100. In some embodiments, the walls of the introducer 6100defining the actuator track 6111 define a friction fit with a portion ofthe guide member 6520. The arrangement of the guide member 6520 withinthe actuator track 6111 can be such that the actuator 6500 issubstantially maintained in a given location, relative to the introducer6100, until a force is applied to the actuator 6500 to move the actuator6500 towards the second configuration. Similarly stated, the actuator6500 engages the introducer 6100 such that the actuator 6500substantially does not move without a user's intervention (e.g.,applying a force to the actuator 6500). In other embodiments, theactuator 6500 need not include a guide member 6520. In such embodiments,the actuator 6500 can be configured to define a friction fit with theintroducer 6100 when the actuator 6500 is disposed about the introducer6100 (e.g., an inner surface of the wall or walls defining the annularshape of the actuator 6500 engage an outer surface of the introducer6100 to define the friction fit).

The coupler 6530 is disposed on a top surface of the guide member 6520(e.g., the guide member 6520 is disposed between the coupler 6530 andthe inner surface of the actuator 6500). As shown in FIGS. 11 and 13,the coupler 6530 is coupled to the proximal end 6220 of the cannula6200. In some embodiments, an outer surface of the proximal end 6220 ofthe cannula 6200 defines a friction fit with the inner surface of thecoupler 6530. In other embodiments, the distal end 6220 of the cannula6200 can be coupled to the coupler 6530 via an adhesive. In this manner,the proximal end 6220 of the cannula 6200 and the coupler 6530 form asubstantially fluid tight seal.

A proximal end 6540 of the actuator 6500 is coupled to a secondarycannula 6250 further configured to be coupled to a container shroud6270. The container shroud 6270 defines a cavity 6271 configured toreceive fluid reservoir (e.g., a conventional phlebotomy fluid containersuch as a Vacutainer®). More specifically, secondary cannula 6250defines a lumen 6253 and includes a proximal end 6252 configured to becoupled to a lock mechanism 6524. The lock mechanism 6524 can beconfigured to be coupled to the container shroud 6270. In addition, thelock mechanism 6524 includes a needle 6525 disposed within a sheath 6526configured to pierce a portion of the fluid reservoir (e.g., asdescribed above with reference to FIG. 3) when the fluid reservoir (notshown) is disposed within the container shroud 6270. Therefore, with theproximal end 6220 of the cannula 6200 coupled to the coupler 6530 andthe secondary cannula 6250 coupled to the proximal end 6540 of theadapter 6500, the adapter 6500 is configured to place the cannula 6200(e.g., the lumen 6201 defined by the cannula 6200) in fluidcommunication with the secondary cannula 6250 (e.g., the lumen 6253 ofthe secondary cannula 6250) and the fluid reservoir (not shown).

While described as including the secondary cannula 6250, in someembodiments, the apparatus 6000 need not include the secondary cannula6250. In such embodiments, the cannula 6200 can define a continuousfluid path (e.g., lumen 6201) from the distal end 6230, through theconnector 6530, and to the container shroud 6270. In other embodiments,the container shroud 6270 can be configured to be physically andfluidically coupled to the actuator 6500.

The adapter 6400 can be any suitable adapter 6400. For example, in someembodiments, an adapter can be a known Y-adapter or T-adapter (e.g., adual port IV extension set). In other embodiments, an adapter can besimilar in form and function to the adapter 5400, described above withreference to FIGS. 7 and 8. As shown in FIG. 10, the adapter 6400 is aT-style adapter and includes a distal end 6410, a first port 6420, and asecond port 6430. The distal end 6410 defines a port and includes a lockmechanism 6411 configured to be coupled to the peripheral intravenousline 6300. In this manner, the lock mechanism 6411 can be any suitableknown lock mechanism such that the distal end 6410 of the adapter 6400can engage a known PIV 6300.

The first port 6420 can be coupled to a distal end 6427 of an inletcatheter 6425. In some embodiments, the distal end 6427 of the inletcatheter 6425 forms a friction fit with an inner surface of the firstport 6420. In some embodiments, the distal end 6427 of the inletcatheter 6425 can include a fitting configured to engage the first port6420 (e.g., a threaded fitting). In other embodiments, the inletcatheter 6425 can be monolithically formed with the first port 6420 ofthe adapter 6400. The inlet catheter 6425 further includes a proximalend 6426 configured to couple to a lock mechanism 6428. In this manner,the inlet catheter 6425 can be engaged by a user (e.g., a physician,nurse, or the like) to administer a fluid (e.g., a medicine or the like)to the peripheral intravenous line and thus, the vein of a patient. Insome embodiments, the inlet catheter 6425 is substantially similar inform and function as known inlet catheters. Therefore, with the adapter6400 coupled to the PIV 6300 and the PIV 6300 disposed within a patient,a user can administer a given fluid to the patient via the inletcatheter 6425 without requiring further training in the functioning ofthe adapter 6400.

In use, a user (e.g., a phlebotomist) can engage the actuator 6500 ofthe blood draw apparatus 6000 to move the actuator 6500 in the distaldirection, as indicated by the arrow EE in FIG. 12. In this manner, theactuator 6500 moves in the distal direction relative to the introducer6100 to place the apparatus in the second configuration. As describedabove, the user can apply a sufficient amount of force to the actuator6500 such that the friction between the walls of the introducer 6100 andthe guide member 6520 of the actuator 6500 is overcome. With the cannula6200 coupled to the coupler 6530 of the actuator 6500, the cannula 6200is moved in the distal direction concurrently with the actuator 6500toward the second configuration.

As indicated by the arrow FF in FIG. 13, the cannula 6200 is advancedthrough the seal member 6132 included in the lock mechanism 6131,through a lumen 6401 defined by the adapter 6400 and through the PIV6300 such that the distal end 6230 of the cannula 6200 extends beyondthe PIV 6300. In this manner, the distal end 6230 of the cannula 6200 issubstantially disposed within the vein of the patient such that thelumen 6201, defined by the cannula 6200, is in fluid communication withthe vein. As shown in FIG. 13A, the cannula 6200 can be advanced throughthe PIV 6300 such that a distal surface 6206 of the first portion 6205of the cannula 6200 is placed in contact with a proximal surface 6301 ofa portion of the PIV 6300. Thus, the distal surface 6206 of the cannula6200 engages the proximal surface 6301 of the PIV 6300 to prevent thecannula 6200 from being advanced beyond the second configuration.Similarly stated, the distal surface 6206 is configured to contact theproximal surface 6301 of the portion of the PIV 6300 to limit the travelof the cannula 6200. While the first portion 6205 and the second portion6210 of the cannula 6200 shown in FIG. 13A include a substantiallysimilar inner diameter, in other embodiments, the first portion 6205 canhave a substantially larger inner diameter than the second portion 6210.In some embodiments, an inner wall or a set of inner walls that definethe lumen 6201 can include a tapered transition between the firstportion 6205 and the second portion 6210. In other embodiments, theinner wall or walls need not include a tapered portion.

While not shown in FIG. 13, a fluid container (e.g., a Vacutainer®) canbe disposed within the cavity 6271 defined by the container shroud 6270such that the sheath 6256 is withdrawn from the needle 6255 and theneedle 6255 pierces the fluid container, thereby placing the fluidcontainer in fluid communication with the vein of the patient. In otherembodiments, the fluid container can be monolithically formed with thecontainer shroud 6270 and/or with the introducer such that the movementof the actuator 6500 can urge the needle 6255 to pierce the fluidcontainer. In some embodiments, the fluid container is configured todefine a negative pressure (e.g., a Vacutainer®). In such embodiments,when the needle 6255 pierces the fluid container, the negative pressurewithin the fluid container introduces a suction force within the lumen6253 of the secondary cannula 6250 and the lumen 6201 of the cannula6200. The suction force is such that a bodily fluid (e.g., blood) isdrawn through the lumen 6201 of the cannula 6200 and the lumen 6253 ofthe secondary cannula 6250 and into the fluid container, as indicated bythe arrow GG in FIG. 13. In this manner, a phlebotomist can collect(e.g., draw) a given amount of blood through an existing peripheralintravenous line without the need for additional needle sticks.

With the desired amount of bodily fluid collected, the user (e.g.,phlebotomist) can move the actuator 6500 in the proximal direction,thereby placing the apparatus 6000 in a third (used) configuration, asindicated by the arrow HH in FIG. 14. In the third configuration, thecannula 6200 is substantially fluidically isolated from a volume outsidethe introduce 6100. Therefore, the introducer 6100 (e.g., the lockmechanism 6131) can be decoupled from the second port 6430 of theadapter 6400 and safely discarded.

While the apparatus 6000 (shown and described with respect to FIGS.9-14) includes a single piece introducer 6100, in some embodiments, anapparatus can include a multi-piece introducer configured for telescopicmotion. For example, FIGS. 15-22 illustrate an apparatus 7000 accordingto an embodiment. As shown in FIGS. 15-17, the apparatus 7000 includesan introducer 7100 and a cannula 7200 and is configured to be movedbetween a first configuration (FIG. 15) and a second configuration(FIGS. 16 and 17), as described in further detail herein.

The introducer 7100 includes a first member 7150 defining a first lumen7155 and a second member 7160 defining a second lumen 7165. In someembodiments, the first member 7150 is a substantially cylindrical tubehaving a first diameter and the second member 7160 is a substantiallycylindrical tube having a second diameter, larger than the firstdiameter. In this manner, the lumen 7165 defined by the second member7160 is configured to receive at least a portion of the first member7155. More specifically, the first member 7150 is movably disposedwithin the second member 7165 such that the introducer 7100 can be movedin a telescopic motion. Similarly stated, the second member 7160 isconfigured to move between a first position and a second position,relative to the first member 7150. Furthermore, the second member 7160includes an actuator portion 7500 configured to be engaged by a user(e.g., a phlebotomist) to move the second member 7160 relative to thefirst member 7150.

The introducer 7100 includes a proximal end 7120 and a distal end 7130.The proximal end 7120 includes a port 7121. The port 7121 can be anysuitable port. For example, in some embodiments, the port 7121 issubstantially similar to the port 1121, described above with referenceto FIGS. 1 and 2. In this manner, the port 7121 is configured to receivea portion of the catheter 7200, as described in further detail herein.The distal end 7130 can be coupled to a lock mechanism 7131. The lockmechanism 7131 can be any suitable mechanism such as, for example, aLuer Lok™. In some embodiments, the lock mechanism 7131 can besubstantially similar to the lock mechanism 6131 described above withreference to FIGS. 9-14. Therefore, the lock mechanism 7131 is notdescribed in further detail herein.

The introducer 7100 is configured to receive at least a portion of thecannula 7200. More specifically, the cannula 7200 includes a proximalend 7220 and a distal end 7230 and is at least partially disposed withinthe introducer 7100 such that the proximal end 7220 of the cannula 7200extends through the port 7121 of the introducer 7100. In this manner,the cannula 7200 is configured to move relative to at least a portion ofthe introducer 7100 between a first configuration and a secondconfiguration, as further described herein.

The proximal end 7220 of the cannula 7200 is coupled to a lock mechanism7221. The lock mechanism 7221 can be any suitable lock mechanism, suchas, for example, a Luer Lok™. Furthermore, the lock mechanism 7221 iscoupled to a needle 7222 such that when the proximal end 7220 of thecannula 7200 is coupled to the lock mechanism 7221, a lumen (not shownin FIGS. 15-22) defined by the cannula 7200 is placed in fluidcommunication with a lumen (not shown in FIGS. 15-22) defined by theneedle 7222. The distal end 7230 of the cannula 7200 includes a firstportion 7205, having a first diameter, and a second portion 7210, havinga second diameter, smaller than the first diameter. As shown in FIG. 17,the cannula 7200 is configured to include a taper between the firstportion 7205 and the second portion 7210. The taper can be any suitableconfiguration and can be substantially similar to the taper portion 4203described above with reference to FIG. 5.

As shown in the exploded view of FIG. 18, the lock mechanism 7131 isconfigured to be coupled to an adapter 7400. The adapter includes adistal end 7410, a first port 7420, and a second port 7430. The adapter7400 can be any suitable adapter described herein. For example, in someembodiments, the adapter can be substantially similar to the adapter6400 described above with reference to FIGS. 9-14. In other embodiments,the adapter 7400 can be any known adapter, such as, for example, aY-adapter or a T-adapter. In this manner, the first port 7420 of theadapter 7400 is configured to be coupled to an inlet catheter 7425. Theinlet catheter 7425 can be any suitable configuration. In someembodiments, the inlet catheter 7425 is substantially similar in formand function to the inlet catheter 6425 described above with referenceto FIGS. 9-14. Therefore, the inlet catheter 7425 is not described indetail herein.

The second port 7430 is configured to be coupled to the lock mechanism7131. In this manner, the second port 7430 and the lock mechanism 7131can be configured to form a substantially fluid tight seal. For example,in some embodiments, the second port 7430 can include a threadedcoupling configured to engage a threaded coupling of the lock mechanism7131, thereby defining the substantially fluid tight seal. Furthermore,the lock mechanism 7131 can include a seal member (not shown in FIGS.15-22) configured to selectively fluidically isolate a lumen 7113defined by the introducer 7100 from a lumen (not shown) defined by theadapter. For example, in some embodiments, the seal member can besubstantially similar in form and function to the seal member 6132described above with reference to FIG. 11. The distal end 7410 of theadapter 7400 is configured to be coupled to a peripheral intravenousline (PIV) 7300. In some embodiments, the PIV 7300 is a known PIV. Inthis manner, the distal end 7410 of the adapter 7400 can include anysuitable feature configured to physically and fluidically couple theadapter 7400 to the PIV 7300.

As shown in FIG. 19, the apparatus 7000 can be in the firstconfiguration such that the second member 7260 of the introducer 7100 isdisposed in a proximal position relative to the first member 7150 of theintroducer 7100. In use, a user (e.g., a phlebotomist) can engage theactuator 7500 included in the second member 7160 of the introducer 7100and move the second member 7160 in the distal direction, as indicated bythe arrow II in FIG. 20. In this manner, the introducer 7100 moves in atelescopic motion such that the second member 7160 moves relative to thefirst member 7150. Similarly stated, an overall length of the introducer7100 is reduced when the second member 7160 moves relative the firstmember 7150. Furthermore, the distal movement of the second member 7160is such that the cannula 7200 is moved in the distal direction. In thismanner, the distal end 7230 of the cannula 7200 passes through the sealmember included in the lock mechanism 7131 (as similarly described abovein reference to FIGS. 11 and 13) and through the PIV 7300. As shown inthe enlarged view of FIG. 22, the distal end 7230 of the cannula 7200extends beyond the PIV 7300 to place a lumen (not shown) defined by thecannula 7200 in fluid communication with a portion of a body of apatient (e.g., a vein). Furthermore, in some embodiments, the adapter7400 can be configured to include a seal member 7470 configured toreceive the cannula 6200. In this manner, the seal member 7470 canprevent a backflow of a bodily fluid into, for example, the introducer7100.

With the apparatus 7000 in the second configuration (e.g., FIGS. 20-22),the user can dispose a fluid container (e.g., a Vacutainer®, or anyother suitable fluid container) within a container shroud 7270 such thatthe container engages the needle 7222. In this manner, the needle 7222can pierce a portion of the fluid container (not shown) to place thefluid container in fluid communication with the lumen defined by thecannula 7200. In addition, with the distal end 7230 of the cannula 7200disposed within, for example, the vein of the patient, the fluidcontainer can be placed in fluid communication with the vein. In someembodiments, such as those where the fluid container is a Vacutainer® orthe like, the fluid container can define a negative pressure (e.g., thefluid container is an evacuated container). In such embodiments, thenegative pressure defined by the fluid container can introduce a suctionforce to the lumen defined by the cannula 7200 such that a bodily fluid(e.g., blood) is drawn through the cannula 7200 and into the fluidcontainer. In this manner, a phlebotomist can collect (e.g., draw) agiven amount of blood through an existing peripheral intravenous linewithout the need for additional needle sticks.

While the apparatus 7000 described above with reference to FIGS. 15-22includes an introducer 7100 with a first member 7150 and a second member7160, in some embodiments, an apparatus can include an introducer withany suitable number of portions or members. For example, FIGS. 23 and 24illustrate an apparatus 8000 according to an embodiment. The apparatus8000 includes at least an introducer 8100 and a cannula or catheter 8200and is configured to be moved between a first configuration (FIG. 23)and a second configuration (FIG. 24).

The introducer 8100 includes a first member 8150, a second member 8160,and a third member 8170. In some embodiments, the first member 8150 canhave a first diameter, the second member 8160 can have a seconddiameter, larger than the first diameter, and the third member 8170 canhave a third diameter, larger than the second diameter. In this manner,at least a portion of the first member 8150 can be movably disposedwithin the second member 8160. Similarly, at least a portion of thesecond member 8160 can be movably disposed within the third member 8170.In this manner, the introducer 8100 can be configured to be moved in atelescopic motion, as similarly described above with respect to theintroducer 7100.

As shown in FIGS. 23 and 24, the first member 8150 includes a set ofprotrusions 8156 disposed at a proximal end 8151 and a distal end 8152of the first member 8150. The second member 8160 similarly includes aset of protrusions 8166 and a set of grooves 8167 disposed at a proximalend 8161 and a distal end 8162 of the second member 8160. In a similarmanner, the third member 8170 includes a set of grooves 8177 disposed ata proximal end 8171 and a distal end 8172 of the third member 8170. Theset of protrusions 8156 and 8166 are configured to selectively engagethe set of grooves 8167 and 8177, respectively, as described in furtherdetail herein.

The introducer 8100 includes a proximal end 8120 and a distal end 8130.The proximal end 8120 is configured to receive a portion of the catheter8200. More specifically, the catheter 8200 is movably disposed withinthe introducer 8100 such that a proximal end 8220 extends through theproximal end 8120 of the introducer 8100. The distal end 8130 of theintroducer 8100 is coupled to a lock mechanism 8131. The lock mechanism8131 can be any suitable lock mechanism described herein. Therefore, thelock mechanism 8131 is not described in further detail.

The catheter 8200 includes the proximal end 8220 and a distal end 8230.As described above, the proximal end 8220 is configured to extendthrough the proximal end 8120 of the introducer 8100 when the catheter8200 is disposed within the introducer 8100. The proximal end 8220 iscoupled to a lock mechanism 8221. The lock mechanism 8221 is furthercoupled to a needle 8222 and a sheath 8223. The lock mechanism 8221, theneedle 822, and the sheath 8223 can be substantially similar in form andfunction to the lock mechanism 2221, the needle 2222, and the sheath2223, respectively, described above with reference to FIG. 3. Therefore,the lock mechanism 8221, the needle 8222 and the sheath 8223 are notfurther described herein.

As shown in FIG. 23, the apparatus 8000 can be in the firstconfiguration such that the introducer 8100 is in a non-collapsedconfiguration. Similarly stated, the third member 8170 of the introducer8100 is in a proximal position, relative to the second member 8160, andthe second member 8160 is in a proximal position, relative to the firstmember 8150. Expanding further, in the first configuration, the grooves8167 disposed at the distal end 8162 of the second member 8160 are incontact with the protrusions 8156 disposed at the proximal end 8151 ofthe first member 8150. Similarly, the grooves 8177 disposed at thedistal end 8172 of the third member 8170 are in contact with theprotrusions 8166 disposed at the proximal end 8161 of the second member8160. The arrangement of the protrusions 8156 and 8166 within thegrooves 8167 and 8177, respectively, is such that the introducer 8100 ismaintained in the non-collapsed (e.g., extended or telescopedconfiguration). Furthermore, the protrusions 8156 and 8166 can form afriction fit with a surface defining the grooves 8167 and 8177. In thismanner, the introducer 8100 can be maintained within the firstconfiguration until an external force is applied to the introducer 8100to move the introducer towards the second configuration.

For example in use, a user (e.g., a phlebotomist) can engage theintroducer 8100 and apply a given force, as indicated by the arrow JJ inFIG. 24. In this manner, the applied force can be such that the thirdmember 8170 moves in the distal direction relative to the second member8160. Similarly, the second member 8160 is moved in the distal directionrelative to the first member 8150 (e.g., the applied force issufficiently large to overcome the friction force between theprotrusions 8156 and 8166 and the surface defining the grooves 8167 and8177, respectively). Therefore, the introducer 8100 is moved to thesecond configuration in which the introducer 8100 is substantiallycollapsed or compressed. Furthermore, the relative distal movement ofthe third member 8170 and the second member 8160 is such that the set ofgrooves 8167 at the proximal end 8161 and the distal end 8162 of thesecond member 8160 engage the set of protrusions 8156 at the proximalend 8151 and the distal end 8152, respectively, of the first member8150. Similarly, the set of grooves 8177 at the proximal end 8171 andthe distal end 8172 of the third member 8170 engage the set ofprotrusions 8166 at the proximal end 8161 and the distal end 8162 of thesecond member 8160.

In this manner, the introducer 8100 is in the second configuration andthe set of protrusions 8156 and 8166 engage the surfaces defining theset of grooves 8167 and 8177 to define a friction fit. Thus, theintroducer 8100 is maintained in the second configuration. Furthermore,the telescopic motion of the introducer 8100 is such that the catheter8200 disposed within the introducer 8200 is advanced through the lockmechanism 8131, as shown in FIG. 24. As described herein, the lockmechanism 8131 can be coupled to any suitable adapter and/or peripheralintravenous line. Therefore, when in the second configuration, thecatheter 8200 extends beyond the PIV to draw a portion of a bodilyfluid, as described herein (e.g., similar to the apparatus 7000described herein with reference to FIGS. 15-22).

While the apparatus 6000 described above with reference to FIGS. 9-14includes an annular shaped actuator 6500, in some embodiments, anapparatus can include any suitable actuator. For example, FIGS. 25 and26 illustrate an apparatus 9000 according to an embodiment, in a firstconfiguration and a second configuration, respectively. The apparatus9000 includes an introducer 9100, a cannula 9200, and an actuator 9570.The introducer 9100 includes a proximal end 9120 and a distal end 9230and defines a lumen 9113. The distal end 9230 is configured to becoupled to a lock mechanism 9131. The cannula 9200 includes a proximalend 9220 and a distal end 9230 and defines a lumen 9201. The introducer9100 and the cannula 9200 can be substantially similar in form andfunction to any introducer and cannula/catheter described herein.Therefore, the introducer 9100 and the cannula 9200 are not described infurther detail herein.

As shown in FIG. 25, the actuator 9570 can be configured to be a styletor wire. In this manner, the actuator 9570 can be movably disposedwithin the cannula 9200. Furthermore, the actuator 9570 can besufficiently stiff such as to advance the cannula 9200 through theintroducer 9100, the lock mechanism 9131, and an existing PIV (not shownin FIGS. 25 and 26) substantially without kinking or creasing. Theactuator 9570 can be configured to be moved in the proximal directionrelative to the cannula 9200, as indicated by the arrow KK in FIG. 26.In this manner, the actuator 9570 can be removed from the cannula 9200and the cannula 9200 can be placed in fluid communication with a fluidcontainer. Thus, the cannula 9200 can facilitate a transfer of a bodilyfluid from a patient to the fluid container, as described above.

While the embodiments described herein have included an introducer, insome embodiments, an apparatus need not include an introducer. Forexample, FIGS. 27 and 28 illustrate an apparatus 10000 according to anembodiment, in a first configuration and a second configuration,respectively. The apparatus 10000 can include a cannula or catheter10200 with a proximal end 10220 and a distal end 10230. The cannula10200 can be substantially similar in form and function to anycannula/catheter described herein. For example, in some embodiments, theproximal end 10220 includes a lock mechanism 10221, a needle 10222, anda sheath 10223, substantially similar to the lock mechanism 2221, theneedle 2222, and the sheath 2223 described above with respect to FIG. 3.

The catheter 10200 is coupled to a handle 10590 configured to be engagedby a user (e.g., a phlebotomist). The apparatus 10000 can furtherinclude a lock mechanism 10131. The lock mechanism 10131 can besubstantially similar in form and function to the lock mechanism 6131described above with reference to FIG. 11. Therefore, in use, a user cancouple the lock mechanism 10131 to a peripheral intravenous line (PIV)10300 and define a fluid tight seal. With the lock mechanism 10131coupled to the PIV 10300, the user can engage the handle 10590 coupledthe catheter 10200 to advance the catheter 10200 through the lockmechanism 10131 and the PIV 10300, as indicated by the arrow LL in FIG.28. Thus, the catheter 10200 can be placed in fluid communication with afluid container and with the catheter 10200 extended beyond the PIV10300, the catheter 10200 can facilitate a transfer of a bodily fluidfrom a patient to the fluid container, as described above.

While specific cannulas or catheters are described herein as including adistal end of a particular configuration (i.e., with circumferentialopenings, etc.), in some embodiments the distal end of the catheter orcannula can include a different structure configured to facilitate thedrawing of blood through the catheter. For example, FIG. 29 illustratesa catheter 11200 that includes a distal end 11230 with a bullet-shapedtip 11232. The bullet-shaped tip 11232 includes an end portion 11233that defines a single opening 11234 at a distal end surface of thebullet-shaped tip.

In some embodiments, such as, for example, a catheter 11200′ shown inFIG. 30, a bullet-shaped tip 11232′ includes an end portion 11233′ thatdefines an end opening 11234′. In such embodiments, the bullet-shapedtip 11232′ includes a set of side-wall openings 11231′. The end opening11234′ and the side openings 11231′ can be configured to produce alaminar flow and act to transport a bodily fluid (i.e., blood) to avolume outside the catheter 11200′. While the openings 11231, 11231′,11234, and 11234′ are illustrated as having a particular configuration,the shape and orientation/relative position of the openings can bevaried to facilitate the fluid flow through the catheter.

As shown in FIG. 31 the bullet-shaped tip 11232″ can be configured toinclude a substantially closed rounded end portion 11233″. In thismanner, the bullet-shaped tip 11232″ can be used to move through clotsexisting within a peripheral intravenous line. The bullet-shaped tip11232″ includes a set of sidewall openings 11231″ that are operative totransport a bodily fluid (i.e., blood) to a volume outside the catheter11200″.

In some embodiments, for example as shown in FIGS. 32-34, a catheter12200 includes a distal end 12230 with a wireframe tip 12241 having astent-like configuration. The wireframe tip 12241 can be a flexible meshconfigured to extend away from the distal end 12230 of the catheter12200. The wireframe tip 12241 can act to transport a bodily flow (i.e.,blood) to a volume outside the catheter 12200. In some embodiments, thewireframe tip 12241 can include a capped end 12242. The capped end 12242can be any suitable size, shape, or configuration and, in someembodiments, can include any suitable number of openings.

In some embodiments, the wireframe tip 12241 can be connected to a guidewire 12243 and used without an additional catheter, as shown in FIGS.35-37. Similarly stated, the wireframe tip 12241 can be inserted into anexisting peripheral intravenous line via a guide wire and without thecatheter of FIG. 10. In this manner, the wireframe tip 12241 can act asa stent and support the walls of the vein such that blood can be drawnthrough the existing peripheral intravenous line. In such aconfiguration, the wireframe tip 12241 can be positioned within theexisting peripheral intravenous line at any suitable location. Forexample, the wireframe tip can be positioned adjacent the distal end ofthe intravenous line.

As described above with reference to FIGS. 9-14, the blood drawapparatus 6000 can be coupled to the adapter 6400 which is furthercoupled to the PIV 6300. As stated, the adapter 6400 can be any suitableadapter. For example, in some embodiments, an adapter 13400 can be anyof the adapters 13400 shown in FIGS. 38-43. In such embodiments, theadapters 13400 can be dual port adapters such as Y-adapters orT-adapters. In such embodiments, the adapters 13400 can include anysuitable locking mechanisms, valves, coupling members, seal members,and/or the like, described herein.

While FIGS. 38-43 illustrate dual port adapters 13400, in someembodiments, an adapter can include a single port. For example, in someembodiments, an adapter 14400 can be either adapter 14400 shown in FIGS.44 and 45. In such embodiments, the adapter 14400 includes a single portconfigured to administer a fluid and/or withdraw a fluid to or from thebody.

FIG. 46 is a flowchart illustrating a method for drawing blood through aperipheral intravenous line. In some embodiments, a method 100 includescoupling an introducer sheath to a peripheral intravenous line (PIV), at102. For example, in some embodiments, the introducer sheath can includea locking mechanism disposed at a distal end portion configured toengage a known PIV. In this manner, the locking mechanism can physicallyand fluidically couple at least a portion of the introducer with thePIV. In some embodiments, an adapter is disposed between the PIV and thelocking mechanism.

The introducer sheath is configured to house, at least partially, acatheter. The method 100 further includes advancing the catheter from afirst position, in which the catheter is substantially within theintroducer, to a second position in which the catheter is substantiallyoutside the introducer, at 104. For example, in some embodiments, thecatheter is at least operatively coupled to an actuator such that a usercan engage the actuator to move the catheter in a distal direction,relative to the introducer. Thus, the catheter moves in the distaldirection and can be advanced through the locking mechanism, the adapter(if present), and the PIV. Furthermore, the catheter can be advancedsuch that a distal end of the catheter extends beyond the PIV and into aportion of a patient (e.g., a vein).

The method 100 includes coupling a container to a proximal end of theintroducer sheath such that the container is fluidically coupled to thecatheter, at 106. In some embodiments, a proximal end of the catheterincludes a needle configured to pierce a portion of a fluid container,such as, for example, a Vacutainer®. In this manner, the catheter isplaced in fluid communication with the fluid container. Morespecifically, with the catheter disposed within, for example, a vein ofthe patient, the fluid container is placed in fluid communication withthe vein. In this manner, a desired amount of a bodily fluid (e.g.,blood) can be drawn from the patient and stored in the fluid container.

With the desired amount of bodily fluid collected, the method 100 caninclude withdrawing the catheter from the second position towards thefirst position, at 108. In this manner, the catheter can be moved in theproximal direction such that the distal end of the catheter is againdisposed within the introducer. With the distal end of the catheterdisposed within the introducer, the introducer and/or the lockingmechanism can be configured to fluidically isolate the catheter from avolume outside the introducer. Thus, the introducer and catheter can besafely disposed of without concern of spreading fluid borne pathogens.

FIGS. 47-68 illustrate an apparatus 15000 (also referred to herein as afluid transfer device) according to another embodiment. The fluidtransfer device 15000 can be any suitable shape, size, or configurationand can be coupled to a PIV (not shown in FIGS. 47-68), for example, viaan adapter and/or locking mechanism. As described in further detailherein, the fluid transfer device 15000 can be manipulated to advance acatheter through an existing and/or placed PIV (i.e., when the fluidtransfer device 15000 is coupled thereto) such that at least an endportion of the catheter is disposed in a distal position relative to thePIV. Moreover, with peripheral intravenous lines each having a shape,size, and/or configuration that can vary based on, for example, amanufacturer of the PIV and/or its intended usage, the fluid transferdevice 15000 can be arranged to allow the fluid transfer device 15000 tobe coupled to a PIV having any suitable configuration and subsequently,to advance at least a portion of a catheter through the PIVsubstantially without kinking, snagging, breaking, and/or otherwisereconfiguring the catheter in an undesirable manner.

As shown in FIG. 47, the fluid transfer device 15000 includes anintroducer 15100, a catheter 15200, an actuator 15570, and an adapter15450. The adapter 15450 can be any suitable adapter such as, forexample, a Y-adapter or a T-adapter. For example, in this embodiment,the adapter 15450 is a T-adapter including a first port 15451 coupled tothe introducer 15100, a second port 15452 coupled to a cannula 15455,which in turn, is coupled to a coupler 15456, and a third port 15453that can be coupled to the PIV (not shown). In some embodiments, theports 15451, 15452, and 15453 can be and/or can include a Luer Lok™ orthe like that can fluidically seal the ports 15451, 15452, 15453 whenthe adapter 15450 is not coupled to a device (e.g., the fluid transferdevice 15000, a PIV, etc.). In some embodiments, the adapter 15450 canbe substantially similar to any of the adapters described in detailabove (e.g., the adapters 6400, 7400, and/or 13400). As such, theadapter 15450 is not described in further detail herein.

The introducer 15100 of the fluid transfer device 15000 includes a firstmember 15150 and a second member 15160. The introducer 15100 can be anysuitable shape, size, or configuration. For example, in someembodiments, the introducer 15100 can be disposed in and/or can have asubstantially telescopic arrangement such as those described above withreference to the apparatus 7000 and/or 8000. In some embodiments, theintroducer 15100 can have a shape that is, for example, similar to asyringe or the like. As shown in FIGS. 47-52, the first member 15150includes a proximal end portion 15151, a distal end portion 15152, andan inner surface 15153. The inner surface 15153 defines an inner volume15155 and a channel 15157. As shown in FIG. 48, the first member 15150includes a first half 15150A and a second half 15150B, which can becoupled together (e.g., via ultrasonic welding, an adhesive, amechanical fastener, one or more tabs, snaps, pins, and/or the like) toform the first member 15150. In some embodiments, coupling the firsthalf 15150A to the second half 15150B (e.g., during a manufacturingprocess) to form the first member 15150 can facilitate a process ofmanufacturing the first member 15150. For example, in some embodiments,forming the first member 15150 from the first half 15150A and the secondhalf 15150B can reduce undesirable variations in the shape and/or sizeof the inner surface 15153 (e.g., due to draft angles and/ormanufacturing tolerances) during manufacturing, which can in someinstances, reduce a likelihood of kinks, bends, and/or deformations ofthe catheter 15200 during use of the fluid transfer device 15000.

In other embodiments, a first member 15150 can be monolithically formed(e.g., via injection molding and/or any other suitable manufacturingprocess). That is to say, the first member 15150 can be formed from asingle work piece or the like rather than two work pieces namely, thefirst half 15150A and the second half 15150B. Thus, when referring tofeatures of the first member 15150, such features can be formed and/ordefined by the first half 15150A, formed and/or defined by the secondhalf 15150B, collectively formed and/or defined by the first half 15150Aand the second half 15150B, or, when the first member 15150 is formedfrom a single work piece, formed and/or defined by a correspondingportion of the first member 15150. For example, in this embodiment, thefirst half 15150A and the second half 15150B collectively form theproximal end portion 15151, the distal end portion 15152, and the innersurface 15153 of the first member 15150.

As shown in FIGS. 49 and 50, the proximal end portion 15151 of the firstmember 15150 includes an engagement flange 15159 extending in a radialdirection from an outer surface of the first member 15150. Thearrangement of the engagement flange 15159 can allow a user to engagethe engagement flange 15159 to manipulate a portion of the fluidtransfer device 15000, as described in further detail herein. The distalend portion 15152 of the first member 15150 includes and/or is otherwisecoupled to a locking mechanism 15131. The locking mechanism 15131 can besubstantially similar to any of those described herein. In someembodiments, the locking mechanism 15131 can be a Luer Lok™ or the like.As such, a first end of the locking mechanism 15131 is coupled to thedistal end portion 15152 of the first member 15150 and a second end,opposite the first end, is coupled to the adapter 15450 (e.g., the firstport 15451). Alternatively, in some instances, the second end of thelocking mechanism 15131 can be coupled directly to the PIV (not shown inFIGS. 47-68).

As shown in FIG. 50, the lock mechanism 15131 includes a seal member15190 that is in contact with, for example, a distal surface of thefirst member 15150 to define a substantially fluid tight seal. In use,the seal member 15190 can receive a portion of the second member 15160to allow the portion of the second member 15160 and/or the cannula 15200to be advanced beyond the seal member 15190 in the distal directionwhile maintaining a substantially fluid tight seal around the portion ofthe second member 15160, thereby substantially preventing a backflow offluid into the introducer 15100. The seal member 15190 can be anysuitable configuration such as, for example, an O-ring, a one-way valve,a diaphragm, a self-healing diaphragm, a check valve, or any othersuitable seal member such as those described herein. While shown anddescribed as being included in the locking mechanism 15131, in someembodiments, a seal can be included in the locking mechanism 15131, theadapter 15450, and/or the first member 15150, as described above.Moreover, the seal member 15190 can contact the portion of the secondmember 15160 in such a manner that a friction force is definedtherebetween. In some instances, the friction force is sufficient toselectively limit movement of the second member 15160 relative to thefirst member 15150, as described in further detail herein.

As shown in FIGS. 50-52, the first member 15150 includes a set ofannular walls or the like, which form the inner surface 15153. The innersurface 15153 can define a cross-sectional area with any suitable shapeand/or size. For example, a cross-sectional area defined by the innersurface 15153 (i.e., the cross-sectional area of the inner volume 15155)can be substantially circular with a size that is sufficient to receiveat least a portion of the second member 15160, the catheter 15200,and/or the actuator 15570. Thus, the inner volume 15155 defined by theinner surface 15153 can be substantially cylindrical with a size that issufficient to receive at least a portion of the second member 15160.That is to say, the inner surface 15153 can have a diameter and/or aperimeter that is larger than a diameter and/or perimeter of an outersurface of the second member 15160, as described in further detailherein. While shown and described as being substantially cylindrical, inother embodiments, the inner volume 15155 can have any suitable shapeand/or size. For example, in some embodiments, the inner surface 15153can define a substantially D-shaped cross-sectional area (e.g.,semi-circular). In other embodiments, the inner surface 15153 can have across-sectional shape that is varied along a length of the first member15150.

As described above, the inner surface 15153 defines the channel 15157.The channel 15157 extends along a length of the first member 15150between the proximal end portion 15151 and the distal end portion 15152,as shown in FIG. 50. More particularly, the arrangement of the channel15157 as defined by the inner surface 15153 is such that the channel15157 does not extend through the proximal end portion 15151 or thedistal end portion 15152. In other words, the channel 15157 does notextend the entire length of the first member 15150. Thus, at least adistal end portion the channel 15157 is bounded by the inner surface15153. In addition, the channel 15157 is in fluid communication with theinner volume 15155. Said another way, the channel 15157 can be includedin and/or otherwise encompassed by the inner volume 15155. Said yetanother way, the inner surface 15153 can define a volume that includes afirst portion (e.g., the inner volume 15155) and a second portion (e.g.,the channel 15157).

As shown in FIGS. 51 and 52, the arrangement of the inner surface 15153can be such that the channel 15157 has a first cross-sectional area CA₁at or near the proximal end portion 15151 of the first member 15150(FIG. 51) and a second cross-sectional area CA₂ at or near a distal endportion 15152 of the first member 15150 (FIG. 52). For example, in someembodiments, the channel 15157 can be configured to fan-out, flare,and/or otherwise widen along a length of the first member 15150 in thedistal direction. As described in further detail herein, a portion ofthe second member 15160 can be disposed in the channel 15157 and aportion of inner surface 15153 defining the channel 15157 can define,for example, a range of motion associated with the second member 15160relative to the first member 15150.

As shown in FIGS. 53 and 54, the second member 15160 of the introducer15100 includes a proximal end portion 15161, a distal end portion 15162,an outer surface 15163 having a first protrusion 15164, and an innersurface 15168 having a second protrusion 15169. The second member 15160also includes and/or is otherwise coupled to a guide member 15180. Thesecond member 15160 can have any suitable shape, size, or configuration.For example, as shown in FIG. 53, the second member 15160 can have asubstantially cylindrical shape. That is to say, the outer surface 15163of the second member 15160 defines and/or has a substantially circularcross-sectional shape. In some embodiments, the size and/or shape of thesecond member 15160 can be associated with and/or can substantiallycorrespond to the size and/or shape of the inner surface 15153 of thefirst member 15150. Thus, at least a portion of the second member 15160can be inserted into the first member 15150 and can be movable thereinbetween, for example, a proximal position and a distal position (e.g., atelescopic motion).

As described above with reference to the first member 15150, the secondmember 15160 includes a first half 15160A and a second half 15160B,which can be coupled together (e.g., via ultrasonic welding, anadhesive, a mechanical fastener, one or more tabs, snaps, pins, and/orthe like) to form the second member 15160. In other embodiments, thesecond member 15160 can be monolithically formed (e.g., via injectionmolding and/or any other suitable manufacturing process). Thus, whenreferring to features of the second member 15160 it should be understoodthat such features can be formed and/or defined by the first half15160A, formed and/or defined by the second half 15160B, collectivelyformed and/or defined by the first half 15160A and the second half15160B, or, when the second member 15160 is formed from a single workpiece, formed and/or defined by a corresponding portion of the secondmember 15160. For example, in this embodiment, the first half 15160A andthe second half 15160B collectively form the proximal end portion 15161and the distal end portion 15162 of the second member 15160.

The inner surface 15168 of the second member 15160 defines an innervolume 15165. The inner surface 15168 can define a cross-sectional areawith any suitable shape and/or size. For example, a cross-sectional areadefined by the inner surface 15168 (i.e., the cross-sectional area ofthe inner volume 15165) can have a substantially circularcross-sectional shape with a size that is sufficient to receive at leasta portion of the actuator 15570 (e.g., the size is larger than across-sectional size of at least a portion of the actuator 15570). Asshown in FIG. 54, the second member 15160 can include a seal member15167 disposed in a distal most position within the inner volume 15165and about a portion of the guide member 15180. As such, the seal member15167 forms a substantially fluid tight and/or substantially hermeticseal about the guide member 15180. The seal member 15167 can be anysuitable shape, size, and/or configuration. For example, in someembodiments, the seal member 15167 can be formed from a flexiblematerial such as silicone, rubber, and/or any other suitable elastomericmaterial. In some embodiments, the seal member 15167 can be configuredto absorb a bodily fluid that might otherwise flow in the proximaldirection into the inner volume 15165 (e.g., a flow of bodily fluidsubstantially outside of the catheter 15200). For example, in someembodiments, the seal member 15167 can be formed from an absorbentmaterial such as POREX® or the like. Moreover, the second protrusion15169 extends from the inner surface 15168, for example, at or near theproximal end portion 15161 of the second member 15160. As described infurther detail herein, the second protrusion 15169 can engage a portionof the actuator 15570 when the actuator 15570 is disposed within theinner volume 15165.

The first protrusion 15164 of the second member 15160 extends from theouter surface 15163 at or near the distal end portion 15162 of thesecond member 15160. Said another way, the first protrusion 15164extends in a radial direction from the outer surface 15163. As such,when the second member 15160 is disposed within the inner volume 15155of the first member 15150, the first protrusion 15164 is disposed in thechannel 15157, as shown in FIG. 55.

The arrangement of the introducer 15100 is such that when the secondmember 15160 is moved relative to the first member 15150, the firstprotrusion 15164 is moved within the channel 15157. As such, the channel15157 (and/or the portion of the inner surface 15153 defining thechannel 15157) defines a range of motion for the second member 15160relative to the first member 15150. For example, with the channel 15157extending along the length of the first member 15150 from the proximalend portion 15151 to the distal end portion 15152, the range of motionassociated with the second member 15160 as defined by the channel 15157includes an axial motion (e.g., a distal and/or proximal direction) ofthe second member 15160 within the first member 15150 between itsproximal position and its distal position. Similarly, the increasedwidth associated with the second cross-sectional area CA₂ can define,for example, a rotational range of motion about a longitudinalcenterline CL of the first member 15150 (see e.g., FIG. 55), asdescribed in further detail herein.

In some embodiments, the range of motion associated with a rotation ofthe second member 15160 (also referred to herein as “rotational range ofmotion”) is dependent on an axial position of the second member 15160along the longitudinal centerline CL of the first member. For example,in some embodiments, the inner surface 15153 defining a portion of thechannel 15157 can be, for example, relatively tapered or the like suchthat the rotational range of motion continuously increases until thesecond member 15160 is disposed in a distal position relative to thefirst member 15150. In other embodiments, the inner surface 15153 caninclude any number of steps or rings with each step or ring beingassociated with a portion of the channel 15157 corresponding to adiscrete rotational range of motion. By way of example, the innersurface 15153 can include a first ring associated with a rotationalrange of motion of about 30 degrees, a second ring distally adjacent tothe first ring and associated with a rotational range of motion of about90 degrees, and a third ring distally adjacent to the second ring andassociated with a rotational range of motion of about 180 degrees.

With the channel 15157 not extending through the proximal end portion15151 or the distal end portion 15152 of the first member 15150 (asdescribed above), the axial movement of the second member 15160 relativeto the first member 15150 is limited to a length of the channel 15157.Thus, at least a portion of the second member 15160 is maintained in theinner volume 15155 and substantially prevented from being retractedtherethrough. Furthermore, a portion of the inner surface 15153 defininga proximal end portion of the channel 15157 can include, for example, arib 15158 (e.g., a ridge, a protrusion, a bump, etc.) that can beconfigured to at least temporarily maintain the first protrusion 15164and thus, the second member 15160 in the proximal position relative tothe first member 15150, as described in further detail herein.

Referring back to FIGS. 53 and 54, the guide member 15180 includes aproximal end portion 15181 and a distal end portion 15182. The proximalend portion 15181 is coupled to and/or otherwise extends from the distalend portion 15162 of the second member 15160. More specifically, theproximal end portion 15181 of the guide member 15180 is disposed withinthe seal member 15167, which in turn, is disposed in the inner volume15165 of the second member 15160. As shown in FIG. 54, at least aportion of the seal member 15167 is disposed in a proximal positionrelative to the guide member 15180. In other words, the proximal endportion 15181 of the guide member 15180 does not extend through the sealmember 15167 disposed within and/or coupled to the distal end portion15162 of the second member 15160, as described in further detail herein.

In this embodiment, the guide member 15180 can be, for example, acannula, a catheter, and/or the like. As such, the guide member 15180defines a lumen 15183 that movably receives a portion of the catheter15200. As described in further detail herein, the arrangement of thesecond member 15160 and the guide member 15180 is such that when thesecond member 15160 is disposed in the proximal position relative to thefirst member 15150, the guide member 15180 is disposed in the firstmember 15150 and when the second member 15160 is moved to the distalposition relative to the first member 15150, the distal end portion15182 of the guide member 15180 at least partially extends beyond, forexample, a distal end of a PIV (not shown). Moreover, the second member15160 is disposed in the inner volume 15155 of the first member 15150 insuch a manner that the guide member 15180 extends through the sealmember 15190. Thus, the seal member 15190 is in contact with an outersurface of the guide member 15180 to define the substantially fluidtight seal, as described above.

The guide member 15180 can be formed from any suitable material with astiffness sufficient to allow the guide member 15180 to be passedthrough a hub of a PIV substantially without kinking, breaking, and/orotherwise plastically deforming. For example, in some embodiments, theguide member 15180 can be a metal hypotube or the like with a hardness(e.g., intrinsic to the material used to form the guide member 15180)and/or a stiffness (e.g., dependent on both material, size, and shape ofthe guide member 15180) sufficient to allow the guide member 15180 topass through any suitable hub configuration included in a PIV as thesecond member 15160 is moved from the proximal position to the distalposition. As described in further detail herein, the guide member 15180can be advanced through at least a portion of an PIV so that the distalend portion 15182 is in a distal position relative to at least the hubor basket of the PIV and once placed in a desired position, the catheter15200 can be advanced within the lumen 15183 defined by the guide member15180 in the distal direction so that at least a portion of the catheter15200 is disposed distal to the guide member 15180. Thus, thearrangement of the guide member 15180 and the catheter 15200 limitsand/or substantially prevents a kinking, bending, breaking, pinching,and/or other form of deformation of the catheter 15200 as the catheter15200 is moved in the distal direction.

Although the guide member 15180 is shown and described as being acannula, catheter, and/or hypotube, in other embodiments, a guide membercan be any suitable configuration. For example, in some embodiments, aguide member can be an elongate structure with a substantially V-shapedor U-shaped cross-section. Such a guide member can, for example, definea channel or the like configured to receive and/or guide a portion of acatheter. In other embodiments, the guide member 15180 can be a braidedwire, a conduit, a coil, a spiral, a rail, and/or any other suitablemember configured to receive and/or guide a portion of a catheter. Thus,the arrangement and/or configuration of the guide member 15180 can beassociated with an amount of stiffness sufficient to allow the guidemember 15180 to be passed through a PIV and/or sufficient to guide thecatheter 15200 to reduce, for example, a likelihood of the catheter15200 being kinked when being moved within the introducer 15100.

As shown in FIGS. 56-60, the actuator 15570 of the fluid transfer device15000 includes a proximal end portion 15571 and a distal end portion15572 and defines a slot 15573. The proximal end portion 15571 includesan engagement portion 15579 that can be substantially similar to theengagement portion 15159 of the first member 15150. For example, a usercan engage the engagement portion 15579 to manipulate at least theactuator 15570 of the fluid transfer device 15000, as described infurther detail herein. The proximal end 15540 is coupled to a secondarycannula 15250 that includes a coupler 15254, which in turn, isconfigured to be coupled to a fluid reservoir (e.g., a Vacutainer® orthe like (not shown in FIGS. 47-68)). As described in further detailherein, the actuator 15570 is coupled to the catheter 15200 such thatwhen the coupler 15254 is coupled to the fluid reservoir, the catheter15200 is placed in fluid communication with the fluid reservoir.

The actuator 15570 can have any suitable shape, size, or configuration.For example, as shown in FIG. 56, the second member 15160 can have asubstantially cylindrical shape. In some embodiments, the size and/orshape of the second member 15160 can be associated with and/or cansubstantially correspond to the size and/or shape of the inner surface15168 of the second member 15160. In this manner, at least a portion ofthe actuator 15570 can be inserted into the inner volume 15165 definedby the second member 15160 and can be moved there in between, forexample, a proximal position and a distal position (e.g., a telescopicmotion). More specifically, as shown in FIGS. 59 and 60, the actuator15570 can be disposed within the inner volume 15165 of the second member15160 in such a manner that the second protrusion 15169 extending fromthe inner surface 15168 is disposed within the slot 15573 defined by theactuator 15570. Thus, as the actuator 15570 is moved in an axial motion(e.g., in the distal direction or the proximal direction) relative tothe second member 15160, the second protrusion 15169 is moved within theslot 15573. As described above, in some embodiments, the actuator 15570can be disposed between the first half 15160A and the second half 15160Bof the second member 15160 prior to being coupled. Thus, the secondprotrusion 15169 can be inserted into the slot 15573 defined by theactuator 15570. In other embodiments, the second protrusion 15169 can bemovable so as to allow the actuator 15570 to be inserted into the innervolume 15165, as described above with reference to the first member15150.

In some embodiments, a length of the slot 15573 can define a range ofmotion of the actuator 15570 relative to the second member 15160.Moreover, with the slot 15573 not extending through the proximal endportion 15571 or the distal end portion 15572 of the actuator 15570 (seee.g., FIGS. 56 and 57), at least a portion of the actuator 15570 ismaintained in the inner volume 15165 and substantially prevented frombeing retracted therethrough, as described with reference to the secondmember 15160). Furthermore, a surface of the actuator 15570 defining adistal end portion of the slot 15573 can include, for example, aprotrusion, a ridge, a rib, a bump, etc. that can be configured to atleast temporarily maintain the first protrusion 15164 in a distalposition relative to the actuator 15570, as shown in FIG. 60. Thus, theactuator 15570 can be maintained in the proximal position relative tothe second member 15160 prior to use, as described in further detailherein.

The actuator 15500 is coupled to the catheter 15200 and is configured tomove the catheter 15200, relative to the introducer 15100, between afirst configuration and a second configuration, as described in furtherdetail herein. The catheter 15200 of the fluid transfer device 15000 hasa proximal end 15206 and a distal end 15212 and defines a lumen 15209therethrough (see e.g., FIGS. 56-62). As described above with referenceto FIG. 5, the catheter 15200 includes a first portion 15205 (e.g., aproximal portion) having a first diameter and a second portion 15210(e.g., a distal portion) having a second diameter, smaller than thefirst (see e.g., FIG. 56). In some embodiments, the diameter of thecatheter 15200 at the second portion 15210 can, for example, facilitatethe insertion of the catheter 15200 into the peripheral intravenousline, as described in further detail herein. In some embodiments, thecatheter 15200 can be between a 16-gauge and 26-gauge and have a Shoredurometer of about 20 Shore A to about 95 Shore D. In other embodiments,the catheter 15200 has a Shore durometer of about 20 Shore A to 50 ShoreD. In still other embodiments, the catheter 15200 has a Shore durometerof about 70 Shore D to 85 Shore D.

In some embodiments, the first portion 15205 of the catheter 15200 canhave a Shore durometer that is greater than a Shore durometer of thesecond portion 15210. For example, in some embodiments, the firstportion 15205 can be formed from a first material or first blend ofmaterials and the second portion can be formed from a second material orsecond blend of materials having a durometer less than a durometer ofthe first material or first blend of materials. In some embodiments, thefirst portion 15205 and the second portion 15210 can be, for example,co-extruded. In other embodiments, the first portion 15205 can be, forexample, over-molded about a portion of the second portion 15210. Instill other embodiments, the second portion 15210 can be formed bydrawing an end of the first portion 15205. As such, the first portion15205 can have a stiffness and/or durometer that is sufficient toinhibit a kinking, a pinching, a breaking, and/or an undesirable plasticdeformation of the first portion 15205 while being advanced, forexample, through the introducer 15100, as described in further detailherein. The second portion 15210 can have a stiffness and/or durometerthat is less than the stiffness and/or durometer of the first portion15210 and as such, can be configured to bend, flex, elastically deform,and/or otherwise reconfigure, which, in some instances, can reduce alikelihood of the second portion 15210 puncturing a vascular tissue whendisposed therein and/or allow the second portion 15210 to be advancedthrough a kink, bend, turn, valve, and/or obstruction in, for example, alumen defined by a PIV, as described in further detail herein.

The first portion 15205 of the catheter 15200 is coupled to the actuator15570. More specifically, as shown in FIG. 57, the first portion 15205of the catheter 15200 extends a length of the actuator 15570 such thatthe proximal end 15206 of the catheter 15200 is disposed at or near theproximal end portion 15571 of the actuator 15570. In this manner, thelumen 15209 defined by the catheter 15200 is placed in fluidcommunication with the secondary catheter 15250, as described in furtherdetail herein. The second portion 15210 of the catheter 15200 can bearranged in any suitable manner. For example, in some embodiments, thedistal end 15212 of the catheter 15200 (i.e., disposed at an end of thesecond portion 15210) can include a substantially open end-surfaceconfigured to place the lumen 15209 in fluid communication with, forexample, a vein. In some embodiments, the distal end 15212 can includethe open end-surface and any number of openings disposed on the side(e.g., circumference) of the catheter 15200, as described above.

As shown in FIG. 62, in this embodiment, the distal end 15212 of thecatheter 15200 is angled or beveled. In some instances, a beveled distalend 15212 can facilitate the advancement of the catheter 15200 through akink or bend, for example, by rotating the catheter 15200 to align abevel angle with a kink angle or the like. In other embodiments, thedistal end 15212 can be any suitable configuration such as, for example,substantially flat, bullet-shaped, conical, bulbous, or the like. Instill other embodiments, the distal end 15212 can be substantially open(as shown in FIG. 62) and can include one or more slits, cuts, grooves,channels, and/or the like that substantially traverse a distal surfaceof the distal end 15212. In such embodiments, the slits can introduce adiscontinuity in and/or along a portion of the distal end 15212, whichin some embodiments can decrease a stiffness of the distal end 15212 byallowing, for example, an elastic deformation of the distal end 15212.In some instances, an elastic deformation (i.e., non-permanent) of thedistal end 15212 can facilitate the advancement of the catheter 15200past and/or through kinks, bends, corners, etc. within a vascularstructure, a portion of the PIV, and/or the like.

As shown in FIGS. 60-62, the arrangement of the actuator 15570 and thecatheter 15200 is such that when the actuator 15570 is disposed withinthe second member 15160 of the introducer 15100 at least a portion ofthe catheter 15200 is disposed in the guide member 15180. Morespecifically, when the actuator 15570 is disposed in the proximalposition relative to the second member 15160, the second portion 15210of the catheter 15200 is disposed in the guide member 15180. When theactuator 15570 is moved to the distal position relative to the secondmember 15160, the second portion 15210 of the catheter 15200 at leastpartially extends beyond the distal end portion 15182 of the guidemember 15180, as described in further detail herein.

Expanding further, a portion of the catheter 15200 is disposed in andextends through the seal member 15167 of the second member 15160. Assuch, an outer surface of a portion of the catheter 15200 that isdisposed in the seal member 15167 and that is proximal to the guidemember 15180 is in contact with the seal member 15167 and as such, theseal member 15167 forms a substantially fluid tight seal with the outersurface of that portion of the catheter 15200. Thus, with the catheter15200 disposed in the guide member 15180 and the seal member 15167forming a substantially fluid tight seal with the distal end portion15181 of the guide member 15180 and the portion of the catheter 15200,the seal member 15167 inhibits and/or substantially prevents a bodilyfluid inside of the guide member 15180 but outside of the catheter 15200from flowing into a volume proximal to the seal member 15167. Simplystated, the seal member 15167 can engage the guide member 15180 and thecatheter 15200 to inhibit bodily fluid from leaking into a volumeproximal to the seal member 15167.

As shown in FIGS. 59-60, prior to use, the fluid transfer device 15000can be disposed in a first configuration (e.g., an expandedconfiguration), in which the second member 15160 is disposed in itsproximal position relative to the first member 15150 and the actuator15570 is disposed in its proximal position relative to the second member15160. In this manner, the guide member 15180 is disposed within thefirst member 15150 of the introducer 15100 and at least the secondportion 15210 of the catheter 15200 is disposed within the guide member15180. Expanding further, as shown in FIG. 59, the catheter 15200 is atleast partially disposed in the introducer 15100 when the fluid transferdevice 15000 is in the first configuration. In some embodiments, theinner volume 15165 of the second member 15160 and the inner volume 15155of the first member can be substantially fluidically sealed such thatthe inner volumes 15165 and 155 are each substantially sterile. As aresult, at least a portion of the catheter 15200 is maintained in asubstantially sterile environment prior to use.

While the first portion 15205 of the catheter 15200 is shown, forexample, in FIG. 58 as extending through the slot 15573 of the actuator15570 and thus, being exposed to an ambient environment, in otherembodiments, the actuator 15570 and/or catheter 15200 can include a bag,a cover, a wrapper, a sleeve, and/or the like that can be disposed aboutthe portion of the catheter 15200 that extends through the slot 15573 ofthe actuator 15570 to maintain the portion of the catheter 15200 in asubstantially sterile environment. Thus, the first portion 15205 and thesecond portion 15210 can be substantially sterile prior to use. In otherembodiments, the second member 15160 of the introducer 15100 caninclude, for example, a sterilization member (e.g., a sponge, a wipe, aseal, etc.) disposed within the inner volume 15160 that can beconfigured to contact an outer surface of the catheter 15200, therebysterilizing a portion of the catheter 15200 when the catheter 15200 ismoved relative to the second member.

While in the first configuration, a user (e.g., a phlebotomist) canmanipulate the fluid transfer device 15000 to couple the first member15150 of the introducer 15100 to the adapter 15450 (see e.g., FIG. 59).In other embodiments, the fluid transfer device 15000 can be, forexample, pre-assembled with the adapter 15450. In still otherembodiments, the fluid transfer device 15000 can be used without theadapter 15450. In this embodiment, the locking mechanism 15131 disposedat the distal end portion 15152 of the first member 15150 is coupled tothe first port 15451 of the adapter 15450. Although not shown in FIGS.59-68, the third port 15453 of the adapter 15450 can be coupled to aPIV. As a result, the introducer 15100 is coupled (e.g., indirectly viathe adapter 15450 or directly when used without the adapter 15450) tothe PIV. Although not shown in FIGS. 59-68, the coupler 15254 disposedat the end of the secondary cannula 15250 can be coupled to a fluidreservoir or the like to place the lumen 15209 of the catheter 15200 influid communication with the fluid reservoir.

Once coupled to the PIV and the fluid reservoir, the user can engage theengagement portion 15159 of the first member 15150 and the engagementportion 15579 of the actuator 15570 to exert a force on the actuator15579. More particularly, by engaging the engagement portion 15159 ofthe first member 15150, a portion of the force exerted on the actuator15579 that would otherwise be exerted on the PIV (e.g., via theintroducer 15100 and the adapter 15450) can be reduced. Said anotherway, the user can exert a reaction force on the engagement portion 15159of the first member 15150 in response to the force applied to theactuator 15570 which is sufficient to reduce and/or substantiallyeliminate a force that would otherwise be transmitted to and exerted onthe PIV.

The force exerted on the engagement portion 15579 of the actuator 15570moves the actuator 15570 and the second member 15160 in the distaldirection relative to the first member 15150, thereby placing the fluidtransfer device 15000 in a second configuration, as indicated by thearrow MM in FIG. 63. More specifically, the actuator 15570 moves thesecond member 15160 from its proximal position to its distal positionrelative to the first member 15150, while the actuator 15570 remains ina relatively fixed position (e.g., its proximal position) relative tothe second member 15160. For example, as described above, a portion ofthe inner surface 15153 defining a proximal end portion of the channel15157 can include, for example, a protrusion, a ridge, a rib, a bump,etc. that can be configured to at least temporarily maintain the firstprotrusion 15164 and thus, the second member 15160 in the proximalposition relative to the first member 15150. Similarly, the rib 15574 ofextending from a surface of the actuator 15570 that defines the slot15573 at least temporarily maintains the second protrusion 15169 in adistal position relative to the actuator 15570 and thus, the actuator15570 is at least temporarily maintained its proximal position relativeto the second member 15160.

As such, the ribs 15158 and 15574 narrow a portion of the channel 15157and the slot 15573, respectively, to a width smaller than a width of thefirst protrusion 15164 and the second protrusion 15169, respectively.Thus, the second member 15160 can be maintained substantially in theproximal position until a force is applied (e.g., either directly orindirectly) to the second member 15160 that is sufficient to move thefirst protrusion 15164 through the narrowed portion of the channel 15157(e.g., associated with the ribs 15158). Thus, in response to a force thefirst protrusion 15164 can exert a portion of the force on the ribs15158 of the inner surface 15153, which in turn, can deform, bend, flex,and/or reconfigure the inner surface 15153 a sufficient amount to allowthe first protrusion 15164 to pass therethrough (and/or to otherwiseovercome a friction force therebetween). In a similar manner, theactuator 15570 can be maintained substantially in the proximal positionuntil a force is applied on the actuator 15570 that is sufficient tomove the second protrusion 15169 through the narrowed portion of theslot 15573 (e.g., associated with the ribs 15574). Thus, in response toa force the second protrusion 15169 can exert a portion of the force onthe ribs 15574 of the actuator 15570, which in turn, can deform, bend,flex, and/or otherwise reconfigure a surface of the actuator 15570 asufficient amount to allow the second protrusion 15169 to passtherethrough (and/or to otherwise overcome a friction forcetherebetween).

As shown in FIG. 63, the actuator 15570 and the second member 15160 arecollectively moved relative to the first member 15150 in response to theapplied force on the engagement portion 15579 of the actuator 15570. Assuch, a portion of the force moves the first protrusion 15164 pastand/or through the ribs 15158 extending from the inner surface 15153 ofthe first member 15150, while the ribs 15574 of the actuator 15570retain the second protrusion 15169 in a substantially fixed position.Thus, a force sufficient to move the second member 15160 relative to thefirst member 15150 is less than a force sufficient to move the actuator15570 relative to the second member 15160. Such an arrangement can, forexample, ensure that the second member 15160 is relative to the firstmember 15150 prior to the actuator 15570 being moved relative to thesecond member 15160. In some embodiments, the movement of the firstprotrusion 15164 past the ribs 15158 can be, for example, associatedwith and/or otherwise result in an indicator such as a haptic, tactile,visual, and/or auditory output. For example, in some embodiments, anindicator can be an auditory output such as a “click.” In otherembodiments, an indicator can be a visual output such as indicia,markings, a status window, a change in color of a status member, adigital output to be presented on a display, and/or the like.

As shown in FIG. 64, the movement of the second member 15160 to thedistal position relative to the first member 15150 advances the guidemember 15180 (coupled thereto) in the MM direction to a position inwhich at least the distal end portion 15182 of the guide member 15180 isdisposed in and extends past an end of the PIV. More specifically, asthe second member 15160 is moved to its distal position, the guidemember 15180 is concurrently advanced through a port or “basket” of thePIV (not shown). As described above, the guide member 15180 isconfigured to have a stiffness and/or is formed from a material(s) witha hardness or durometer that is sufficient to pass through the port ofthe PIV substantially without kinking, breaking, bending, plasticallydeforming (e.g., permanently deforming), etc. Moreover, the guide member15180 can have a length and hardness that is sufficient to pass throughany suitable PIV to dispose at least the distal end portion 15182 in adistal position relative to the end of the PIV. In other words, theguide member 15180 can be arranged such that when the second member15160 is in its distal position relative to the first member 15150, thedistal end portion 15182 of the guide member 15180 is disposed in avascular structure and at least partially outside of the PIV.Furthermore, with the actuator 15570 maintained in a relatively fixedposition relative to the second member 15160, the second portion 15210of the catheter 15200 is maintained within the lumen 15183 defined bythe guide member 15180, as shown in FIG. 64.

With the second member 15160 in its distal position, the applied forceexerted on the engagement portion 15579 moves the actuator 15570 fromits proximal position to its distal position relative to the secondmember 15160. For example, the second member 15160 can be moved throughits range of motion (e.g., defined at least in part by the channel15157) to be disposed in its distal most position and as such, a portionof the applied force that was exerted to move the second member 15160relative to the first member 15150 is instead substantially exerted onthe actuator 15570. As such, the force exerted on the actuator 15570 canbe sufficient to move the second protrusion 15169 past the ribs 15574disposed in the slot 15573 and as a result, the actuator 15570 is movedfrom its proximal position to its distal position relative to the secondmember 15160, as indicated by the arrow NN in FIG. 65. In someembodiments, the movement of the actuator 15570 from its proximalposition to its distal position can be associated with and/or otherwiseresult in an indicator such as a haptic, tactile, visual, and/orauditory output, as described above.

As shown in FIG. 66, the movement of the actuator 15570 to its distalposition relative to the second member 15160 advances the catheter 15200in the NN direction to a position in which at least the distal endportion 15212 of the catheter 15200 is disposed in and extends past thePIV. Moreover, the catheter 15200 can be advanced such that the distalend portion 15212 of the catheter 15200 extends beyond the distal endportion 15182 of the guide member 15180. Thus, the catheter 15200 can bearranged such that when the actuator 15570 is in its distal positionrelative to the second member 15160 and the second member 15160 is inits distal position relative to the first member 15150, the distal endportion 15212 of the catheter 15200 is disposed in a vascular structureand at least partially outside of the PIV and the guide member 15180.Thus, the lumen 15209 of the catheter 15200 can receive a flow of bodilyfluid, which in turn, can flow through the lumen 15209 to be disposed inthe fluid reservoir. For example, in some embodiments, the fluidreservoir can be an evacuated reservoir such as a Vacutainer®, which canexert a suction force through the lumen 15209 of the catheter 15200.Thus, the bodily fluid (e.g., blood) is drawn through the lumen 15209 ofthe cannula 15200 and the lumen 15253 of the secondary cannula 15250 andinto the fluid container. In this manner, a phlebotomist can collect(e.g., draw) a given amount of blood through an existing peripheralintravenous line without the need for additional needle sticks.

As shown in FIGS. 67 and 68, in some embodiments, it may be desirable torotate the catheter 15200 relative to the first member 15150, therebyrotating the distal end 15212 within the vascular structure (e.g., toprevent a suctioning of the distal end 15212 to a wall of the vascularstructure). Thus, in such instances, the user can manipulate, forexample, the actuator 15570 to rotate the actuator 15570 and the secondmember 15160 relative to the first member 15150. More specifically, thearrangement of the second protrusion 15169 within the slot 15573 definedby the actuator 15570 can be such that the actuator 15570 is maintainedin a substantially fixed angular position relative to the second member15160. Thus, manipulation of the actuator 15570 by the user can resultin a rotation of both the actuator 15570 and the second member 15160relative to the first member 15150.

As described above, the channel 15157 can have a cross-sectional shapeand/or area at or near the proximal end portion 15151 of the firstmember 15150 that is associated with and/or slightly larger than a sizeof the first protrusion 15164, thereby limiting the rotational range ofmotion of the second member 15160 when disposed in the proximalposition. With the second member 15160 in the distal position, however,the cross-sectional shape and/or area of the channel 15157 at or nearthe distal end portion 15152 of the first member 15150 (i.e., the secondcross-sectional area CA₂) can allow the second member 15160 to rotateabout 30 degrees, about 60 degrees, about 90 degrees, about 120 degrees,about 180 degrees, about 210 degrees, or more relative to thelongitudinal centerline CL. That is to say, in some embodiments, thesecond member 15160 can rotate in a clockwise motion or acounterclockwise motion about the longitudinal centerline CL andrelative to a center position of the first protrusion 15164 (see e.g.,FIG. 67) in a range between about 0 degrees to about 105 degrees, asindicated by the arrow OO in FIG. 68.

In some instances, such rotation of the actuator 15570 and the secondmember 15160 can, for example, reduce a likelihood of the distal end15212 of the catheter 15200 forming suction against a wall of thevascular structure (e.g., a vein). For example, by rotating the catheter15200 the one or more openings defined by the distal end 15212 are alsorotated, which in turn, can reduce the likelihood of the distal end15212 adhering to a wall of the vascular structure due to a suctionforce within the catheter 15200 (e.g., via an evacuated fluid reservoiror the like). In some instances, it may be desirable to rotate thesecond member 15160 as the actuator 15570 is being moved toward itsdistal position. Such rotation can, in some such instances, facilitatethe advancement of the catheter 15200 by rotating the catheter 15200such that a beveled surface or the like (as described above) is alignedwith a kinked surface of the guide member 15180 and/or vascularstructure. In some instances, the alignment of the beveled surface ofthe catheter 15200 and the kinked surface can facilitate the passage ofthe catheter 15200 though the kinked region.

In some instances, it may be desirable to move the catheter 15200 in anaxial direction relative to the first member 15150 and/or the secondmember 15160. More specifically, the arrangement of the second member15160 and the actuator 15570 is such that the second protrusion 15169 isdisposed within the slot 15573 defined by the actuator 15570 in aposition that is proximal to the protrusions 15574. Thus, the secondprotrusion 15169 can move relatively free within the slot 15563. In someembodiments, however, the catheter 15200 can be disposed within theguide member 15180 such that a friction force is defined therebetween.As such, a movement of the actuator 15570 in the axial direction (i.e.,the proximal direction and/or the distal direction) can similarly,result in an axial movement of the second member 15160 relative to thefirst member 15150.

In other embodiments, it may be undesirable for the second member 15160to move concurrently in the axial direction with the actuator 15570. Forexample, in some instances, such movement of the second member 15160 canplace the distal end portion 15182 of the guide member 15180 in anundesired position relative to, for example, the PIV. In suchembodiments, the arrangement of the guide member 15180 of the secondmember 15160 and the seal member 15190 of the first member 15150 can,for example, limit and/or substantially prevent axial movement of thesecond member 15160 relative to the first member 15150. Morespecifically, as described above, the seal member 15190 is disposedabout the guide member 15180 and can be in contact therewith to defineboth a substantially fluid tight seal as well as an amount of friction.In some embodiments, the amount of friction (i.e., a friction force)and/or an amount of drag can be sufficient to limit and/or substantiallyprevent an axial movement of the second member 15160 relative to thefirst member 15150. Thus, the actuator 15570 can be moved in the axialdirection relative to the second member 15160 until a force is exertedon the second member 15160 that is sufficient to overcome the frictionforce between the seal member 15190 and the guide member 15180. With theactuator 15570 being a substantially fixed angular or rotationalposition relative to second member 15160, however, at least a portion ofa force exerted to rotate the actuator 15570 is transferred to and/orotherwise exerted on the second member 15160 and thus, when the force issufficient to overcome the friction force between the seal member 15190and the guide member 15180, the actuator 15570 and the second member15180 are rotated relative to the first member substantiallyconcurrently.

With the desired amount of bodily fluid collected, the user (e.g.,phlebotomist) can move the actuator 15570 in the proximal direction toretract the catheter 15200. For example, in some instances, the user canexert a force on the engagement portion 15579 of the actuator 15570 inthe proximal direction, which is sufficient to move at least theactuator 15570 from its distal position toward its proximal positionrelative to the second member 15160. In some embodiments, the secondmember 15160 can be configured to be moved at least in part with theactuator 15570 from its distal position toward its proximal positionrelative to the first member 15150. In some instances, the force can besufficient to place the actuator 15570 and the second member 15160 intheir respectively proximal positions. Moreover, the arrangement of theactuator 15570 and the introducer 15100 is such that the actuator 15570is prevented from being removed from the second member 15160 and thesecond member 15160 is prevented from being removed from the firstmember 15150, as described above. Thus, the guide member 15180 and thecatheter 15200 can be disposed in a proximal position relative to adistal end of the first member 15150.

Although the actuator 15570 and the second member 15160 are describedabove as being moved in response to a force exerted in the proximaldirection applied by the user, in other embodiments, the actuator 15570and/or the second member 15160 can be configured to move in the proximaldirection in an at least semi-automatic manner. For example, in someembodiments, the introducer 15100 can include one or more bias membersconfigured to exert a force to move the second member 15160 and/or theactuator 15570 in the proximal direction. Expanding further, the biasmember can exert a reaction force in response to the force exerted onthe actuator 15579. Thus, once a desire volume of bodily fluid isdisposed in the fluid reservoir, the user can remove the force appliedon the actuator 15570 and as a result, the bias member can exert a forceto move the second member 15160 and the actuator 15570 in the distaldirection. In other embodiments, the introducer 15100 can include a biasmember connected to a retraction mechanism. In such embodiments, theuser can place the second member 15160 and the actuator 15570 in therespective distal positions and can further exert a force in the distaldirection that can engage the retraction mechanism (e.g., engages aswitch, a lock, a latch, a tab, a retention member, etc.), which inturn, can actuate the bias member to exert a force on the second member15160 and the actuator 15570 in the proximal direction. In someembodiments, the engagement of the retraction mechanism can beassociated with an indicator such as a haptic, tactile, auditory, and/orvisual output, which can be transitioned from a first state to a secondstate during a retraction process, as described above.

Although the rotational range of motion of the second member 15160relative to the first member 15150 is shown and described above as beingdefined at least in part by the channel 15157, in other embodiments, thefirst member 15150 and the second member 15160 of the introducer 15100can be arranged in any suitable manner. For example, in someembodiments, the inner surface 15153 of the first member 15150 can havea proximal portion having a first cross-sectional shape (e.g.,substantially D-shaped) and a distal portion having a secondcross-sectional shape different from the first shape (e.g.,substantially circular), while the outer surface 15163 of the secondmember 15160 can have a proximal portion having the secondcross-sectional shape and a distal portion having the secondcross-sectional shape. As such, when the second member 15160 is disposedin a proximal position within the inner volume 15155 of the first member15150, the cross-sectional shapes are substantially aligned, which inturn, can limit a rotational motion of the second member 15160 relativeto the first member 15150. Conversely, when the second member 15160 isadvanced to a distal position within the inner volume 15155 of the firstmember 15150, the cross-sectional shapes are not substantially aligned,which in turn, can allow for a rotational motion of the second member15160 relative to the first member 15150.

While the introducer 15100 and the actuator 15570 are particularly shownand described above with reference to FIGS. 47-68, in other embodiments,a device can include an introducer and/or an actuator of any suitableconfiguration while maintaining a substantially similar functionality.For example, FIGS. 69-72 illustrate a first member 16150 included in anintroducer (not shown in FIGS. 69-72) according to another embodiment.As described above, the first member 16150 includes a proximal endportion 16151, a distal end portion 16152, and an inner surface 16153.The inner surface 16153 defines an inner volume 16155 and a channel16157. The distal end portion 16152 of the first member 16150 includesand/or is otherwise coupled to a locking mechanism 16131. The lockingmechanism 16131 can be substantially similar to any of those describedherein. In some embodiments, the locking mechanism 16131 can be a LuerLok™ or the like. As such, a first end of the locking mechanism 16131 iscoupled to the distal end portion 16152 of the first member 16150 and asecond end, opposite the first end, can be coupled to an adapter (e.g.,the adapter 15450 in FIG. 47). Alternatively, in some instances, thesecond end of the locking mechanism 16131 can be coupled directly to aPIV (not shown in FIGS. 69-72).

As shown in FIG. 50, the lock mechanism 16131 includes a seal member16190 that is in contact with, for example, a distal surface of thefirst member 16150 to define a substantially fluid tight seal. In use,the seal member 16190 can receive, for example, a portion of a secondmember included in the introducer and/or a cannula or catheter (e.g.,coupled to an actuator) to be advanced beyond the seal member 16190 inthe distal direction while maintaining a substantially fluid tight sealaround the portion of the second member and/or cannula or catheter,thereby substantially preventing a backflow of fluid into a volumeproximal to the seal member 16190 (and outside of the second memberand/or cannula or catheter). The seal member 16190 can be any suitableconfiguration such as, for example, an O-ring, a one-way valve, adiaphragm, a self-healing diaphragm, a check valve, or any othersuitable seal member such as those described herein (e.g., the sealmember 15190). Moreover, the arrangement of the seal member 16190 can besuch that when in contact with a guide member and/or a catheter, adesired friction force is defined therebetween. In such embodiments, thefriction force can be configured to resist and/or otherwise produce dragin response to an applied force that would otherwise move the guidemember (e.g., coupled to a second member of the introducer, as describedabove with reference to the introducer 15100) in a axial direction. Assuch, the drag produced by the friction force defined between the sealmember 16190 and the guide member can, for example, maintain the guidemember and thus, a second member of the introducer to which it iscoupled, in a substantially fixed position relative to the first memberwhile allowing, for example, the catheter and/or an actuator coupledthereto to move in an axial direction relative to the introducer.

As described above, the inner surface 16153 defines the channel 16157.The channel 16157 extends along a length of the first member 16150between the proximal end portion 16151 and the distal end portion 16152,as shown in FIG. 69. More particularly, the arrangement of the channel16157 as defined by the inner surface 16153 is such that the channel16157 does not extend through the distal end portion 16152. In otherwords, at least a distal end portion the channel 16157 is bounded by theinner surface 16153. Thus, the channel can function in a similar manneras described above with reference to the first member 15150.

As shown in FIGS. 69 and 70, a proximal end portion of the channel 16157can extend in a circumferential direction. More particularly, in someembodiments, the proximal end portion of the channel 16157 can form adogleg 16157A and/or can be substantially L-shaped. In this manner, aportion of the channel 16157 disposed at and/or near the end of thedoglegged portion 16157 can extend through the proximal end portion16151 of the first member 16150. That is to say, the proximal endportion 16151 of the first member 16150 can define a substantiallycircular opening (i.e., associated with the inner volume 16155), whichcan include a notched portion 16157B or key-holed portion correspondingwith an end portion of the dogleg 16157A of the channel 16157. Thus, alimited portion of the channel 16157 can extend through the proximal endportion 16151 of the first member 16150. Similarly stated, the channel16157 can be substantially enclosed and/or bounded by the inner surfaceexcept for the notched portion 16157B.

In some embodiments, such an arrangement can allow, for example, asecond member of the introducer (e.g., substantially similar to thesecond member 15160 of the introducer 15100) to be inserted into thefirst member 16150. In some embodiments, the second member can include aprotrusion (e.g., similar to or the same as the first protrusion 15164of the second member 15160) that is inserted through, for example, thenotched portion 16157B and/or key-holed opening corresponding to thedoglegged portion 16157A of the channel 16157 (as described above). Oncethe protrusion s inserted therethrough, the second member can be rotatedor clocked to an orientation relative to the first member in which theprotrusion is substantially aligned with a portion of the channel 16157that extends from the proximal end portion 16151 of the first member16150 to the distal end portion 16152 of the first member 16150. Thus,with the second member in such an orientation, a proximal movement ofthe second member relative to the first member 16150 is thereby limited.Accordingly, the first member 16150 can function in a substantiallysimilar manner as the first member 15150 described in detail above.

In a similar manner, FIGS. 73-76 illustrate an actuator 16570 accordingto another embodiment. The actuator 16570 includes a proximal endportion 16571 and a distal end portion 16572 and defines a slot 16573.The proximal end 16540 is coupled to a secondary cannula 16250, which inturn, is configured to be coupled to a fluid reservoir (e.g., aVacutainer® or the like (not shown in FIGS. 73-76)). As described indetail above with reference to the actuator 15570 and the catheter15200, the actuator 16570 is coupled to the catheter 16200 such thatwhen the secondary cannula 16250 is coupled to the fluid reservoir, thecatheter 16200 is placed in fluid communication with the fluidreservoir.

As described above, the actuator 16570 is configured to be inserted intoa second member of an introducer (not shown in FIGS. 73-76). Forexample, in some embodiments, the actuator 16570 can be inserted into asecond member that is substantially similar to or the same as the secondmember 15160 described above. As such, the second member can include aninner protrusion (e.g., the second protrusion 15169), which can bedisposed within the slot 16573. More particularly, as shown in FIGS. 75and 76, the actuator 16570 can include an opening 16578 that can beconfigured to provide access to the slot 16573. In some embodiments, adistal end portion of the slot 16573 can include a doglegged portion(e.g., as described above with reference to the first member 16150) suchthat the slot 16573 extends through a side and/or portion of thecircumference of the actuator 16570. Thus, the actuator 16570 can bepartially disposed in the second member and oriented such that theopening 16578 is aligned with the inner protrusion. Once the innerprotrusion is inserted therethrough, the actuator 16570 can be rotatedor clocked to an orientation relative to the second member in which theinner protrusion is substantially aligned with a portion of the slot16573 channel that extends from the proximal end portion 16571 of theactuator 16570 to the distal end portion 16572 of the actuator 16570.Thus, with the actuator 16570 in such an orientation, a proximalmovement of the actuator relative to the second member is therebylimited. Accordingly, the actuator 16570 can function in a substantiallysimilar manner as the actuator 15570 described in detail above.

Referring to FIG. 69, a flowchart is shown illustrating a method 200 ofphlebotomy through a peripheral intravenous line, according to anotherembodiment. The method includes coupling a fluid transfer device to aperipheral intravenous line (PIV), 201. The fluid transfer device can beany suitable device configured for phlebotomy through a PIV. Forexample, in this embodiment, the fluid transfer device can besubstantially similar to the fluid transfer device 15000 described abovewith reference to FIGS. 47-68. As such, the fluid transfer deviceincludes an introducer, an actuator, and a catheter. The introducerincludes a first member and a second member movably disposed within thefirst member, as described above with reference to FIGS. 48-55. Thesecond member is coupled to a guide member. The actuator is movablydisposed in the second member and is coupled to the catheter.

A first force is exerted on the actuator that is sufficient to move thesecond member relative to the first member from a first position, inwhich a guide member coupled to the second member is disposed within thefirst member, to a second position, in which a distal end portion of theguide member is inserted through a port of the PIV, at 202. Moreparticularly, the force exerted on the actuator moves the actuator andthe second member in the distal direction relative to the first member,while the actuator remains in a relatively fixed position (e.g., aproximal position) relative to the second member. For example, in someembodiment, the second member can be configured to move relative to thefirst member in response to a first amount of force and the actuator canbe configured to move relative to the second member in response to asecond amount of force, greater than the first amount of force. Forexample, in some embodiment, the first member can selectively engage aportion of the second member to temporarily retain the second member inthe first position relative to the first member. Similarly, the secondmember can selectively engage a portion of the actuator to temporarilyretain the actuator in a first position relative to the second member,as described in detail above. Furthermore, the guide member can have alength and a hardness that are each sufficient to allow the guide memberto pass through the port of the PIV substantially without kinking,breaking, and/or otherwise plastically deforming.

With the second member in the second position (e.g., a distal position),a second force is exerted on the actuator that is sufficient to move theactuator relative to the second member such that a distal end portion ofthe catheter extends past an end of the peripheral intravenous line, at203. More specifically, the catheter can be at least partially disposedin the introducer prior to the actuator being moved relative to thesecond member such that at least a distal end portion of the catheter isdisposed in the guide member. Therefore, with the actuator coupled tothe catheter, the movement of the actuator relative to the second membermoves the catheter relative to the guide member. In this manner, whenthe actuator is in a distal position relative to the second member, thecatheter can extend through the PIV and the guide member to dispose thedistal end portion of the catheter in a distal position relative to theguide member and the PIV, as described above with reference to FIGS. 65and 66.

In some instances, it may be desirable to rotate the second memberand/or the actuator relative to the first member as the actuator and/orthe second member are being moved relative to the first member. Forexample, as described above in some embodiments, the first member candefine a channel configured to receive a portion of the second member.In this manner, a surface defining the channel can define, for example,a range of motion associated with the second member relative to thefirst member. As described above with reference to FIGS. 51, 52, 67, and68, the channel can define the range of motion of the second memberrelative to the first member that can include, for example, atranslational movement (e.g., in a proximal or distal direction) and arotational movement. In some instances, a portion of the first forceand/or a portion of the second force can rotate the second member andthe actuator relative to the first member. Such rotation can, forexample, facilitate the advancement of the guide member and/or thecatheter through a portion of the PIV and/or the like. In otherinstances, a force can be exerted on the actuator when the distal endportion of the catheter extends past the end of the PIV to limit asuctioning of the distal end portion of the catheter to a vascularstructure in which it is disposed. Thus, the catheter can be rotated toreduce the likelihood of the distal end portion of the cathetersuctioning to a wall of the vascular structure within which it isdisposed and/or to facilitate the advancement of the catheter past anobstruction included within the guide member, the PIV, and/or thevascular structure.

A fluid reservoir is coupled to the fluid transfer device, at 204. Thefluid reservoir can be any suitable reservoir. For example, in someembodiments, the fluid reservoir can be an evacuated reservoir such as aVacutainer® or the like. Moreover, when the fluid reservoir is coupledto the fluid transfer device, the catheter is placed in fluidcommunication with the fluid reservoir. Thus, a bodily fluid can flow(e.g., in response to a negative pressure and/or suction force) from thebody, through the catheter, and into the fluid reservoir. In someinstances, while withdrawing a volume of bodily fluid, it can bedesirable to move at least the distal end portion of the catheter in anaxial direction to, for example, limit and/or substantially prevent asuctioning of the distal end portion of the catheter to, for example,the vascular structure in which it is disposed. In this manner, the usercan exert a force in the distal direction to correspondingly advance thecatheter in the distal direction or can exert a force in the proximaldirection to correspondingly retract the catheter in the proximaldirection (e.g., while still being disposed distal to the PIV).Moreover, in some embodiments, the first member of the introducer caninclude a seal member and/or the like that can engage, for example, theguide member coupled to the second member of the introducer. In suchembodiments, the seal member can contact the guide member such that afriction force sufficient to maintain the second member in asubstantially fixed position as the catheter is moved in the distal orproximal direction is defined therebetween. Thus, the catheter and thus,the actuator can be moved relative to the introducer.

After a volume of bodily fluid is transferred to the fluid reservoir,the catheter is withdrawn from the PIV and disposed within theintroducer, at 205. For example, in some instances, a third force isexerted on the actuator. The third force can be, for example, exerted inthe proximal direction and can be which is sufficient to move at leastthe actuator from a distal position toward a proximal position relativeto the second member. In some embodiment, the third force can be exertedby a user. In other embodiments, the third force can be exerted, forexample, by a bias member or the like in response to an actuation, asdescribed above. In some embodiments, the second member can beconfigured to be moved at least in part with the actuator from a distalposition toward a proximal position relative to the first member.Moreover, the arrangement of the actuator and the introducer is suchthat the actuator is prevented from being removed from the second memberand the second member is prevented from being removed from the firstmember, as described above. Thus, the guide member and the catheter canbe disposed in a proximal position relative to a distal end of the firstmember. In some instances, on the catheter and the guide member aredisposed in the proximal position relative to the distal end of thefirst member, the fluid transfer device can be discarded.

The components of the blood draw apparatus and the Y-adapter can bepackaged together or separately. The Y-adapter can also be sold in apackage with other IV dressing materials. In some embodiments, theY-adapter can remain on the IV as long as the IV is in the patient.

The blood draw apparatus can be used with a variety of peripheral IVs.The apparatus allows efficient blood draw while still maintaining theintegrity of the sample. In some embodiments, for example, the apparatuswill facilitate 20 ml of blood to be drawn in approximately 1-2 minutes.While extracting blood, the blood flow can be laminar to avoidturbulence in the catheter, thereby minimizing hemolysis.

While the blood draw apparatus can be used in a variety of settings (ER,in-patient, etc.), two examples of scenarios are described herein. Inthe first scenario, the patient has a single peripheral IV. In thesecond scenario, which is typically less common, the patient has adedicated second peripheral IV just for phlebotomy purposes. Only oney-adapter is required per patient, and can be attached for the life ofthe IV, for example, which is typically 3-4 days. A new blood drawapparatus (e.g., any of those described above) can be used for eachblood draw.

The assembly of the blood draw apparatus can be the same in eitherscenario. First, the apparatus is coupled to the y-adapter. Second, thecatheter is advanced through the y-adapter and pushed through theperipheral IV catheter into the patient's vein. Once in the vein, asyringe or a negative pressure collection container/tube (e.g., aVacutainer® tube) is connected to the rear port and fluidically coupledto the catheter to draw and store blood.

The following scenario is provided by way of example. The nurse orphlebotomist inserts a peripheral IV into a patient's arm. Theperipheral IV is inserted following standard guidelines and they-adapter is attached. When it is time to draw blood, the provider canturn off the IV, if it is on, for approximately 1-5 minutes to allowmedicine or IV fluids to disperse from the blood-drawing site. To drawthe blood sample, the provider attaches the blood draw apparatus to theblood draw port on the y-adapter, advances the internal catheter throughthe peripheral IV and into the vein. Next, the provider can attach thenegative pressure collection container(s)/tube(s) to the apparatus(i.e., place the tube in fluid communication with the blood drawapparatus) to extract the blood sample. In use, a user can discard, forexample, the first 3-6 ml of the fluid or blood sample as “waste” thenusing the next tube(s) as the intended sample. This “wasting” procedureensures all of the dead space fluid, like saline or medications, iscleared from the vein, peripheral IV and y-adapter as to not contaminatethe testing sample being drawn.

In the scenario in which there is a dedicated peripheral IV line forblood draw purposes, the provider inserts a peripheral IV into one armto administer medicine and another peripheral IV into the opposite armspecifically for blood drawing purposes. When it is time to draw blood,the provider simply follows the steps mentioned above and there is noneed to wait the 1-5 minutes to allow fluid or medicine dispersal as inthe first scenario.

Each of the components discussed herein can be monolithicallyconstructed or can be a combination of parts. For example, in referenceto FIG. 7, the y-adapter 5400 and the introducer 5100 are coupled usinglocking mechanisms 5431 and 5131, respectively. The y-adapter 5400 andthe introducer 5100 can be the same component, wherein the y-adapter5400 is an integral part of the introducer 5100 and vice-versa. By wayof another example, while the first member 15150 of the introducer 15100is shown and described above with reference to FIGS. 48-52 as includingthe first half 15150A and the second half 15150B which are, for example,coupled together during a manufacturing process to form the first member15150, in other embodiments, the first member 15150 can bemonolithically formed.

Similarly, the components described herein can be assembled in anysuitable manner during, for example, a manufacturing process and/or at apoint of use. For example, in some embodiments a manufacturing processassociated with the fluid transfer device 15000 (and/or a devicesubstantially similar to thereto) can include placing the second member15160 in a desired position relative to the first half 15150A or thesecond half 15150B of the first member 15150 prior to the first half15150A and the second half 15150B being coupled together to form thefirst member 15150. Thus, the second member 15160 can be disposedbetween the first half 15150A and the second half 15150 when the firsthalf 15150A and the second half 15150B are coupled together and as aresult, the first protrusion 15164 can be disposed in the channel 15157prior to the first member 15150 being formed, which in some instances,can facilitate the assembly of the fluid transfer device 15000 based atleast in part on the channel 15157 being bounded by the inner surface15153.

In other embodiments, the protrusion 15164 can be, for example, springloaded and/or otherwise configured to be moved in the radial directionrelative to the second member 15160. As such, the first member 15150 canbe formed by a manufacturing process (e.g., by coupling the first half15150A to the second half 15150B) and the second member 15160 can besubsequently disposed in the inner volume 15155. For example, with thefirst half 15150A being coupled to the second half 15150B to form thefirst member 15150, the second member 15160 can be placed in a desiredposition relative to the first member 15150 and the first protrusion15164 can be moved in a radial direction toward a center of the secondmember 15160 such that an end surface of the first protrusion 15164 isdisposed substantially adjacent to the outer surface 15163 of the secondmember 15160. In this manner, the distal end portion 15162 of the secondmember 15160 can be inserted into the inner volume 15155. Moreover, oncethe second member 15160 is placed in a position within the inner volume15155 associated with an alignment of the first protrusion 15164 and thechannel 15157, the first protrusion 15164 can move in the radialdirection away from the center of the second member 15160 (e.g., inresponse to a force exerted by a spring or the like). Thus, the secondmember 15160 need not be disposed between the first half 15150A and thesecond half 15150B prior to the first half 15150A and the second half15150B being coupled together to form the first member 15150.

Other aspects of the apparatus shown and described can be modified toaffect the performance of the apparatus. For example, the openings inthe set of openings described herein at the distal end of the cathetercan be in any arrangement, size shape, and/or number, to createpreferable flow conditions through the catheter. By way of anotherexample, any portion of the catheters described herein can be disposedwithin a substantially sterile sleeve, bag, tube, cover, and/or the likethat can maintain the sterility of the catheter prior to use of thedevice. In addition, while components of the embodiments have beendescribed herein as having a given hardness, durometer, and/orstiffness, in other embodiments, some components can be substantiallyrigid. For example, in some embodiments, the introducer 6100 can beformed from a substantially rigid material. Similarly, any of the guidetubes and/or members described herein can be formed from a rigidmaterial such as, for example, a metal or hard plastic. For example, insome embodiments, a guide member can be a metal hypotube or the like. Insome embodiments, the arrangement of a catheter (e.g., the catheter15200) disposed within a lumen defined by a guide member (e.g., theguide member 15180) can be such that the catheter and the guide membercollectively define a stiffness that is, for example, a sum of astiffness of the catheter and a stiffness of the guide member. Thus, insome embodiments, the guide member can have a stiffness that issubstantially similar to a stiffness of the catheter, wherein acollective stiffness defined thereby is sufficient to allow the guidemember to pass through at least a portion of a PIV (e.g., a hub, abasket, or the like).

By way of another example, any of the catheters, cannulas, flow tubes,and/or the like described herein can include and/or can otherwisereceive, for example, a guide wire, stiffening wire, lattice and/ormatrix structure, stent, balloon, and/or the like that can increase astiffness associated with the catheter and/or otherwise limit and/orsubstantially prevent a kinking, pinching, and/or plastic deformation ofat least a portion of the catheter. For example, in some embodiments,the catheter 15200 can include, for example, a guide wire or the likethat can be disposed in the lumen 15209 while the catheter 15200 isplaced in its distal position, thereby increasing a stiffness associatedwith the catheter 15200. When the distal end 15212 of the catheter 15200is in a desired position relative to the PIV (i.e., distal to a distalend of the PIV), the guide wire can be retracted through the lumen 15209to be removed from the catheter 15200.

While the second portion 15210 (e.g., a distal end portion) of thecatheter 15200 is particularly shown and described above, in otherembodiments, a catheter can have a distal end portion with any suitableconfiguration. For example, FIG. 78 is a schematic illustration of adistal end portion 17212 of a catheter, according to another embodiment.As shown, the distal end portion 17212 of the catheter can define achannel or the like. Expanding further, a first portion of the catheter(not shown in FIG. 78) can have, for example, an annular cross-sectionalshape, while a second portion of the catheter (i.e., the distal endportion 17212) can have, for example, a semi-annular cross-sectionalshape. In other words, the distal end portion 17212 can be, for example,cut, skived, shaved, bisected, and/or the like such that the distal end15212 of the catheter has a semi-circular or semi-annularcross-sectional shape that defines a channel therebetween. Such anarrangement of the distal end portion 17212 can, in some embodiments,allow for a reduced size and/or gauge associated with the distal end17212 of the catheter, which might otherwise be prone to kinks,obstructions, and/or occlusions. Moreover, the semi-annular arrangementof the distal end portion 17212 can increase flow rate through thecatheter, which might otherwise be limited due to a relatively smallinner diameter of the catheter and/or a relatively small distal openingof the catheter.

In still other embodiments, a distal end portion of a catheter such asthose described herein can include and/or can be coupled to a woundwire, a braided wire, a coiled and/or spiraled wire, a helical wire, amesh, and/or the like. By way of example, in some embodiments, a distalend portion of a catheter can include and/or can be formed from arelatively small wound or coiled wire. In some embodiments, such a wirecan be, for example, tightly wound into a substantially solidcylindrical shape, thereby defining a portion of a lumen. In someinstances, such an arrangement can allow at least the distal end portionof the catheter to bend and/or flex substantially without plasticallydeforming as the catheter is advanced in the distal direction. In someembodiments, the wound wire arrangement of the distal end portion canact, for example, as an auger or the like which can be rotated whilebeing advanced in the distal direction to remove, clear, and/or breakapart an obstruction such as, for example, a clot. Moreover, while thecatheter 15200 is particularly shown and described above, in someembodiments, the distal end portion 15212 of the catheter 15200 can haveany suitable configuration such as those described herein.

While various embodiments have been described above, it should beunderstood that they have been presented by way of example only, and notlimitation. Where schematics and/or embodiments described above indicatecertain components arranged in certain orientations or positions, thearrangement of components may be modified. While the embodiments havebeen particularly shown and described, it will be understood thatvarious changes in form and details may be made. For example, while thedevice or apparatus 6000 is shown and described above as including theintroducer 6100 with a relatively small actuator track 6111 (e.g., aslit), in other embodiments, an introducer can be, for example, asubstantially U-shaped channel or the like. In such embodiments, anactuator and a catheter can be at least partially disposed in theintroducer and moved relative thereto, as described herein. Moreover, insuch embodiments, the catheter can be disposed, for example, within asterile bag or sleeve. In other embodiments, the introducer can be, forexample, a guide rail or the like along which an actuator and cathetercan be moved. In such embodiments, the catheter can be disposed, withina sterile bag or sleeve.

Although various embodiments have been described as having particularfeatures and/or combinations of components, other embodiments arepossible having a combination of any features and/or components from anyof embodiments as discussed above. For example, any of the devicesdescribed herein can include an actuator that can be coupled to acatheter and operable in rotating a catheter relative to, for example, aPIV or the like. By way of another example, while the cannula 6200 isshown in FIG. 13A as including the first portion 6205 having the firstdiameter and the second portion 6210 having the second diameter, in someembodiments, a cannula can include a first portion and a second portionof similar diameter. Furthermore, while the first member 15150 of theintroducer 15100 is particularly shown and described as including theseal member 15190, in other embodiments, the first member 15150 caninclude a seal member substantially similar in form and function to theseal member 16190 included in the first member 16150 described abovewith reference to FIGS. 69-72, or vice versa. Similarly, the firstmember 16150 and/or the actuator 16570 (or features included therein)can be included in, for example, the flow transfer device 15000.

By way of another example, any of the catheters and/or cannulasdescribed herein can have a distal end portion with any suitablearrangement. For example, while the distal end portion 15212 of thecatheter 15200 is shown as being substantially cylindrical with anangled or beveled tip, in other embodiments, the distal end portion15212 and/or the second portion 15210 of the catheter 15200 can have anysuitable arrangement. For example, FIG. 79 is a schematic illustrationof a distal end portion 18212 of a catheter according to anotherembodiment. As shown, the distal end portion 18212 defines a set ofopenings 18216 arranged, for example, in a staggered orientation. Morespecifically, the second portion 18210 of the catheter 18200 can definea set of openings disposed along its circumference similar to the set ofopenings 1231, 2231, and/or 4231 described above with reference to thecatheters 1200, 2200, and 4200, respectively. In such embodiments, theset of openings can be substantially circular, oblong, polygonal,elliptical, and/or any other suitable shape, size, or arrangement. Inthis manner, the set of openings 18216 can, for example, increase flowrate into the distal end portion 18212 of the catheter, while thestaggered and/or offset arrangement of the set of openings 18212 canallow the distal end portion 18212 to remain sufficiently stiff as tolimit and/or substantially prevent a collapse of the distal end portion18212.

Where methods and/or schematics described above indicate certain eventsand/or flow patterns occurring in certain order, the ordering of certainevents and/or flow patterns may be modified. Additionally certain eventsmay be performed concurrently in parallel processes when possible, aswell as performed sequentially.

What is claimed is:
 1. An apparatus, comprising: a catheter having aproximal end portion and a distal end portion, the catheter defining alumen extending through the proximal end portion and the distal endportion of the catheter; and an introducer having a first member and asecond member, at least a portion of the second member movably disposedin the first member, a distal end portion of the first member configuredto be coupled to an indwelling peripheral intravenous line, a distal endportion of the second member including a catheter protector, the secondmember configured to be moved relative to the first member between abetween a proximal position and a distal position, the catheterprotector disposed in the first member when the second member is in theproximal position, at least a distal end portion of the catheterprotector configured to be distal to the first member and within theindwelling peripheral intravenous line when the second member is in thesecond position, at least the distal end portion of the catheter beingisolated within the catheter protector and moving with the second memberas the second member is moved between the proximal position and thedistal position, the catheter configured to be moved relative to secondmember when the second member is in the distal position such that thedistal end portion of the catheter is distal to the catheter protector.2. The apparatus of claim 1, further comprising: an adapter defining alumen and configured to be coupled between the introducer and theindwelling peripheral intravenous line, the catheter protectorconfigured to be proximal to the adapter when the second member is inthe proximal position, the catheter protector configured to extendthrough the lumen of the adapter to place at least the distal endportion of the catheter protector distal to the adapter when the secondmember is in the distal position.
 3. The apparatus of claim 1, furthercomprising: an actuator coupled to the catheter, the actuator isconfigured to move the second member relative to the first member fromthe proximal position to the distal position in response to a firstforce exerted on the actuator and the actuator is configured to move thecatheter relative to the second member in response to a second forceexerted on the actuator.
 4. The apparatus of claim 1, wherein thecatheter protector at least partially encloses at least the distal endportion of the catheter when the second member is moved from theproximal position to the distal position.
 5. The apparatus of claim 1,wherein the catheter protector is configured to limit contact betweenthe catheter and an inner portion of the indwelling peripheralintravenous line as the second member is moved from the proximalposition to the distal position.
 6. The apparatus of claim 1, whereinthe distal end of the second member includes a seal configured to be incontact with at least one of an outer surface of the catheter protectoror an outer surface of the catheter to inhibit a flow of bodily fluidinto a volume outside of the catheter and proximal to the seal.
 7. Theapparatus of claim 1, wherein the catheter protector extends through atleast one of a hub, a basket, or a valve of the indwelling peripheralintravenous line when the second member is in the distal position suchthat a distal end surface of the catheter protector is distal to the atleast one of the hub, the basket, or the valve.
 8. The apparatus ofclaim 1, wherein the indwelling peripheral intravenous line is at leastpartially disposed within a vein of a patient, the catheter isconfigured to be moved relative to the second member when the secondmember is in the distal position to place a distal surface of thecatheter within the vein of the patient and distal to a distal surfaceof the indwelling peripheral intravenous line.
 9. The apparatus of claim8, wherein the proximal end portion of the catheter is configured to befluidically coupled to a fluid reservoir, the catheter configured totransfer a volume of blood from the vein, through the lumen of thecatheter, and to the fluid reservoir when the second member is in thedistal position and the catheter is within the vein of the patient anddistal to the distal surface of the indwelling peripheral intravenousline.
 10. An apparatus, comprising: a catheter having a proximal endportion and a distal end portion, the catheter defining a lumenextending through the proximal end portion and the distal end portion ofthe catheter; an introducer defining an inner volume, the introducerhaving a distal end portion configured to be coupled to an indwellingperipheral intravenous line, the introducer configured to transitionbetween a first configuration, in which a catheter protector is disposedwithin the introducer, and a second configuration, in which at least adistal end portion of the catheter protector is distal to the introducerand within the indwelling peripheral intravenous line; and an actuatorcoupled to the catheter and configured to transition the introducerbetween the first configuration and the second configuration, at leastthe distal end portion of the catheter being isolated within thecatheter protector and moving with the catheter protector as theintroducer is transitioned from the first configuration to the secondconfiguration, the actuator configured to move the catheter relative tocatheter protector when the introducer is in the second configurationsuch that the distal end portion of the catheter is distal to thecatheter protector.
 11. The apparatus of claim 10, wherein the catheterprotector at least partially encloses at least the distal end portion ofthe catheter when the introducer is transitioned from the firstconfiguration to the second configuration.
 12. The apparatus of claim10, wherein the catheter protector is disposed in a portion of theindwelling peripheral intravenous line when the introducer is in thesecond configuration, and the catheter protector is disposed between anouter surface of at least the distal end portion of the catheter and aninner surface of the portion of the indwelling peripheral intravenousline prior to the catheter being moved relative to the catheterprotector.
 13. The apparatus of claim 10, wherein the actuator ismaintained in a fixed position relative to a portion of the introducerwhen the actuator transitions the introducer from the firstconfiguration to the second configuration.
 14. The apparatus of claim10, wherein the actuator is maintained in a fixed position relative to aportion of the introducer when the actuator transitions the introducerfrom the first configuration to the second configuration and theactuator is configured to move relative to the portion of the introducerto move the catheter relative to the catheter protector.
 15. Theapparatus of claim 10, wherein the catheter protector has a firststiffness and the catheter has a second stiffness less than the firststiffness.
 16. The apparatus of claim 10, wherein a distal end surfaceof the catheter protector is configured to be disposed within theperipheral intravenous line when the introducer is in the secondconfiguration, the actuator is configured to move the catheter relativeto the catheter protector to place a distal end surface of the catheteroutside of and distal to the peripheral intravenous line.
 17. A method,comprising: coupling a fluid transfer device to a peripheral intravenousline at least partially disposed within a vein of a patient, the fluidtransfer device including an introducer, an actuator, and a cathetercoupled to the actuator; exerting a first force on the actuator totransition the introducer from a first configuration, in which acatheter protector is disposed within the introducer, to a secondconfiguration, in which at least a distal end portion of the catheterprotector is distal to the introducer and within the indwellingperipheral intravenous line, at least the distal end portion of thecatheter being isolated within the catheter protector and moving withthe catheter protector as the introducer is transitioned from the firstconfiguration to the second configuration; exerting a second force onthe actuator to move the catheter relative to the catheter protectorsuch that a distal end portion of the catheter is distal to the catheterprotector; establishing fluid communication between the catheter and afluid reservoir; and withdrawing a volume of bodily fluid from thepatient into the fluid reservoir via the catheter.
 18. The method ofclaim 17, wherein the catheter protector at least partially encloses atleast the distal end portion of the catheter when the introducer istransitioned from the first configuration to the second configuration.19. The method of claim 17, wherein the catheter protector is disposedin a portion of the indwelling peripheral intravenous line when theintroducer is in the second configuration such that prior to exertingthe second force, the catheter protector is disposed between an outersurface of at least the distal end portion of the catheter and an innersurface of the portion of the indwelling peripheral intravenous line.20. The method of claim 17, wherein the catheter protector is configuredto limit contact between the catheter and an inner portion of theindwelling peripheral intravenous line.
 21. The method of claim 17,wherein exerting the second force on the actuator to move the catheterrelative to the catheter protector places a distal end surface of thecatheter within the vein of the patient and distal to a distal endsurface of the peripheral intravenous line.
 22. The method of claim 17,wherein coupling the fluid transfer device to the peripheral intravenousline includes coupling the fluid transfer device to an adapter such thatthe adapter is disposed between the fluid transfer device and theperipheral intravenous line.